ID

43451

Description

ODM derived from http://clinicaltrials.gov/show/NCT00777127

Link

http://clinicaltrials.gov/show/NCT00777127

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00777127 Actinic Keratosis

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
Age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Immunocompetent
Description

Immunocompetent patient.

Data type

boolean

Alias
UMLS CUI 2011AA
C1512656
A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.
Description

A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1274600
SNOMED CT 2011_0131
403204001
UMLS CUI 2011AA
C1274599
SNOMED CT 2011_0131
403203007
A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.
Description

A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.

Data type

boolean

Alias
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0919553
SNOMED CT 2011_0131
371469007
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Willingness to comply with the obligations of the study.
Description

Willingness to comply with the obligations of the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
Description

History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.

Data type

boolean

Alias
UMLS CUI 2011AA
C0489531
LOINC Version 232
MTHU001065
UMLS CUI 2011AA
C0718327
SNOMED CT 2011_0131
386941002
UMLS CUI 2011AA
C0012091
SNOMED CT 2011_0131
7034005
LOINC Version 232
MTHU024758
UMLS CUI 2011AA
C0004057
SNOMED CT 2011_0131
7947003
UMLS CUI 2011AA
C0003211
SNOMED CT 2011_0131
16403005, 372665008
UMLS CUI 2011AA
C0020196
SNOMED CT 2011_0131
38218009
LOINC Version 232
MTHU003533
UMLS CUI 2011AA
C0015237
SNOMED CT 2011_0131
360215002
Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
Description

Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
UMLS CUI 2011AA
C0032992
SNOMED CT 2011_0131
169565003
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
UMLS CUI 2011AA
CL424925
UMLS CUI 2011AA
C1262153
MedDRA 14.1
10062577
UMLS CUI 2011AA
C0457572
SNOMED CT 2011_0131
268458002
UMLS CUI 2011AA
C0458083
SNOMED CT 2011_0131
278994005
UMLS CUI 2011AA
C0021900
SNOMED CT 2011_0131
268460000
MedDRA 14.1
10022745
UMLS CUI 2011AA
C0520483
SNOMED CT 2011_0131
77543007
MedDRA 14.1
10044722
UMLS CUI 2011AA
C0420842
SNOMED CT 2011_0131
268457007
Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Description

Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.

Data type

boolean

Alias
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0870082
SNOMED CT 2011_0131
396228006
MedDRA 14.1
10020649
UMLS CUI 2011AA
C0020564
SNOMED CT 2011_0131
56246009
MedDRA 14.1
10020880
LOINC Version 232
MTHU024506
UMLS CUI 2011AA
C0085664
SNOMED CT 2011_0131
403871001
MedDRA 14.1
10011666
ICD-10-CM Version 2010
L85.8
Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.
Description

Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C0718327
SNOMED CT 2011_0131
386941002
UMLS CUI 2011AA
C0012091
SNOMED CT 2011_0131
7034005
LOINC Version 232
MTHU024758
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0543467
SNOMED CT 2011_0131
83578000
MedDRA 14.1
10051332
LOINC Version 232
MTHU000079
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
Description

Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.

Data type

boolean

Alias
UMLS CUI 2011AA
C0022602
SNOMED CT 2011_0131
201101007
MedDRA 14.1
10000614
ICD-10-CM Version 2010
L57.0
ICD-9-CM Version 2011
702.0
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C0718327
SNOMED CT 2011_0131
386941002
UMLS CUI 2011AA
C0012091
SNOMED CT 2011_0131
7034005
LOINC Version 232
MTHU024758
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
Description

Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.

Data type

boolean

Alias
UMLS CUI 2011AA
C0150349
SNOMED CT 2011_0131
386439008
UMLS CUI 2011AA
C0718327
SNOMED CT 2011_0131
386941002
UMLS CUI 2011AA
C0012091
SNOMED CT 2011_0131
7034005
LOINC Version 232
MTHU024758
UMLS CUI 2011AA
C1268086
SNOMED CT 2011_0131
123037004
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
Description

Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.

Data type

boolean

Alias
UMLS CUI 2011AA
C0037286
SNOMED CT 2011_0131
126488004
MedDRA 14.1
10029098
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0444498
SNOMED CT 2011_0131
264031007
UMLS CUI 2011AA
C0007137
SNOMED CT 2011_0131
28899001
MedDRA 14.1
10041823
UMLS CUI 2011AA
C0006079
SNOMED CT 2011_0131
84999002
MedDRA 14.1
10006059
ICD-10-CM Version 2010
D00-D09
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0007137
SNOMED CT 2011_0131
28899001
MedDRA 14.1
10041823
UMLS CUI 2011AA
C0007117
SNOMED CT 2011_0131
1338007
MedDRA 14.1
10004146
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
Description

Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).

Data type

boolean

Alias
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C1444749
SNOMED CT 2011_0131
410661009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0718327
SNOMED CT 2011_0131
386941002
UMLS CUI 2011AA
C0012091
SNOMED CT 2011_0131
7034005
LOINC Version 232
MTHU024758
UMLS CUI 2011AA
C0035854
SNOMED CT 2011_0131
398909004
MedDRA 14.1
10039218
ICD-10-CM Version 2010
L71.9
ICD-9-CM Version 2011
695.3
UMLS CUI 2011AA
C0033860
SNOMED CT 2011_0131
9014002
MedDRA 14.1
10037153
ICD-10-CM Version 2010
L40
UMLS CUI 2011AA
C0011615
SNOMED CT 2011_0131
24079001
MedDRA 14.1
10012438
ICD-10-CM Version 2010
L20.9
Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
Description

Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).

Data type

boolean

Alias
UMLS CUI 2011AA
C0037274
SNOMED CT 2011_0131
95320005
MedDRA 14.1
10048768, 10040831
LOINC Version 232
MTHU031899
UMLS CUI 2011AA
C2828392
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0678227
SNOMED CT 2011_0131
23981006
UMLS CUI 2011AA
C1299586
SNOMED CT 2011_0131
52925006
UMLS CUI 2011AA
C0582103
SNOMED CT 2011_0131
225886003
UMLS CUI 2011AA
C0013595
SNOMED CT 2011_0131
43116000
MedDRA 14.1
10014184
ICD-10-CM Version 2010
L30.9
Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
Description

Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
CL412323
UMLS CUI 2011AA
C0021747
SNOMED CT 2011_0131
49327004
LOINC Version 232
MTHU021353
UMLS CUI 2011AA
C0004482
SNOMED CT 2011_0131
372574004
LOINC Version 232
MTHU006794
UMLS CUI 2011AA
C0010592
SNOMED CT 2011_0131
387467008
LOINC Version 232
MTHU005140
UMLS CUI 2011AA
C2267033
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0004905
SNOMED CT 2011_0131
116574000
History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
Description

History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).

Data type

boolean

Alias
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0920425
UMLS CUI 2011AA
C0034619
History of any malignant skin tumour having metastasised or where metastasis could be expected.
Description

History of any malignant skin tumour having metastasised or where metastasis could be expected.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007114
SNOMED CT 2011_0131
372130007
MedDRA 14.1
10040808
ICD-10-CM Version 2010
C44.9
UMLS CUI 2011AA
C0027627
SNOMED CT 2011_0131
128462008
MedDRA 14.1
10027449
UMLS CUI 2011AA
C1517001
History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
Description

History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0007222
SNOMED CT 2011_0131
105980002
MedDRA 14.1
10007649
ICD-9-CM Version 2011
429.2
UMLS CUI 2011AA
C0024115
SNOMED CT 2011_0131
19829001
MedDRA 14.1
10025082
ICD-10-CM Version 2010
J98.4
UMLS CUI 2011AA
C0023895
SNOMED CT 2011_0131
235856003
MedDRA 14.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
UMLS CUI 2011AA
C0022658
SNOMED CT 2011_0131
90708001
MedDRA 14.1
10029151
ICD-10-CM Version 2010
N18.9
UMLS CUI 2011AA
C0017178
SNOMED CT 2011_0131
119292006
MedDRA 14.1
10017944
UMLS CUI 2011AA
C0018939
SNOMED CT 2011_0131
191124002
MedDRA 14.1
10061590
ICD-10-CM Version 2010
D75.9
ICD-9-CM Version 2011
289.9
UMLS CUI 2011AA
C0014130
SNOMED CT 2011_0131
362969004
MedDRA 14.1
10014695
LOINC Version 232
MTHU021570
ICD-10-CM Version 2010
E34.9
ICD-9-CM Version 2011
259.9
UMLS CUI 2011AA
C0025517
SNOMED CT 2011_0131
30390004
MedDRA 14.1
10058097
ICD-10-CM Version 2010
E88.9
ICD-9-CM Version 2011
277.9
UMLS CUI 2011AA
C0004936
SNOMED CT 2011_0131
74732009
MedDRA 14.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
UMLS CUI 2011AA
C0027765
SNOMED CT 2011_0131
118940003
MedDRA 14.1
10029202
ICD-10-CM Version 2010
G98.8
ICD-9-CM Version 2011
349.9
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
Mentally Disabled Persons
Description

Mentally incapacitated patient.

Data type

boolean

Alias
UMLS CUI 2011AA
C0079822
Present or history of drug or alcohol abuse within the last 3 years.
Description

Present or history of drug or alcohol abuse within the last 3 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0013146
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
UMLS CUI 2011AA
C0085762
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
UMLS CUI 2011AA
C1299544
SNOMED CT 2011_0131
371435006
UMLS CUI 2011AA
C0221628
SNOMED CT 2011_0131
371434005
Exposure to an investigational product within the last 3 months.
Description

Exposure to an investigational product within the last 3 months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C1517741
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Lack of ability or willingness to give informed consent.
Description

Lack of ability or willingness to give informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Age below 18 years.
Description

Age below 18 years.

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
Description

Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C1709695
UMLS CUI 2011AA
C0681884
UMLS CUI 2011AA
C0681873
UMLS CUI 2011AA
C0525058
Anticipated non-availability for study visits/procedures.
Description

Anticipated non-availability for study visits/procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679106
UMLS CUI 2011AA
C0686905
SNOMED CT 2011_0131
397854000
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0680734
Vulnerable subjects (such as persons kept in detention).
Description

Vulnerable subjects (such as persons kept in detention).

Data type

boolean

Alias
UMLS CUI 2011AA
C1562367
SNOMED CT 2011_0131
417430008
UMLS CUI 2011AA
C0680725
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
Age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Immunocompetent patient.
Item
Immunocompetent
boolean
C1512656 (UMLS CUI 2011AA)
A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.
Item
A study treatment area must be identifiable: Minimum of 5 and maximum of 10 typical visible AKs in one contiguous area of up to 50 cm2 on the face or scalp. The eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border must not be part of this area.
boolean
C0039798 (UMLS CUI 2011AA)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1274600 (UMLS CUI 2011AA)
403204001 (SNOMED CT 2011_0131)
C1274599 (UMLS CUI 2011AA)
403203007 (SNOMED CT 2011_0131)
A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.
Item
A positive histological finding for AK grade I or II (see Section 7.1.1.2). This will be determined from the most suspicious lesion in the STA and there from the most pathological area biopsied during screening visit. This analysis will be done by the central histopathological laboratory.
boolean
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0919553 (UMLS CUI 2011AA)
371469007 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Willingness to comply with the obligations of the study.
Item
Willingness to comply with the obligations of the study.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
Item
History of allergic reaction to imiquimod, diclofenac, acetyl salicylic acid, other non steroidal anti-inflammatory drugs (NSAID), hyaluronic acid, or relevant excipients.
boolean
C0489531 (UMLS CUI 2011AA)
MTHU001065 (LOINC Version 232)
C0718327 (UMLS CUI 2011AA)
386941002 (SNOMED CT 2011_0131)
C0012091 (UMLS CUI 2011AA)
7034005 (SNOMED CT 2011_0131)
MTHU024758 (LOINC Version 232)
C0004057 (UMLS CUI 2011AA)
7947003 (SNOMED CT 2011_0131)
C0003211 (UMLS CUI 2011AA)
16403005, 372665008 (SNOMED CT 2011_0131)
C0020196 (UMLS CUI 2011AA)
38218009 (SNOMED CT 2011_0131)
MTHU003533 (LOINC Version 232)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
Item
Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which result in a low failure rate (i.e. <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
CL424925 (UMLS CUI 2011AA)
C1262153 (UMLS CUI 2011AA)
10062577 (MedDRA 14.1)
C0457572 (UMLS CUI 2011AA)
268458002 (SNOMED CT 2011_0131)
C0458083 (UMLS CUI 2011AA)
278994005 (SNOMED CT 2011_0131)
C0021900 (UMLS CUI 2011AA)
268460000 (SNOMED CT 2011_0131)
10022745 (MedDRA 14.1)
C0520483 (UMLS CUI 2011AA)
77543007 (SNOMED CT 2011_0131)
10044722 (MedDRA 14.1)
C0420842 (UMLS CUI 2011AA)
268457007 (SNOMED CT 2011_0131)
Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
Item
Presence of AK lesions in the STA with clinically marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
boolean
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0870082 (UMLS CUI 2011AA)
396228006 (SNOMED CT 2011_0131)
10020649 (MedDRA 14.1)
C0020564 (UMLS CUI 2011AA)
56246009 (SNOMED CT 2011_0131)
10020880 (MedDRA 14.1)
MTHU024506 (LOINC Version 232)
C0085664 (UMLS CUI 2011AA)
403871001 (SNOMED CT 2011_0131)
10011666 (MedDRA 14.1)
L85.8 (ICD-10-CM Version 2010)
Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.
Item
Any topical AK treatment including imiquimod or diclofenac, or any systemic AK treatment such as systemic retinoids, or any surgical AK treatment at the STA within the last 2 months prior to randomisation.
boolean
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0718327 (UMLS CUI 2011AA)
386941002 (SNOMED CT 2011_0131)
C0012091 (UMLS CUI 2011AA)
7034005 (SNOMED CT 2011_0131)
MTHU024758 (LOINC Version 232)
C1515119 (UMLS CUI 2011AA)
C2267033 (UMLS CUI 2011AA)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
Item
Persisting AK lesion at screening visit following topical treatment with imiquimod or diclofenac in the STA.
boolean
C0022602 (UMLS CUI 2011AA)
201101007 (SNOMED CT 2011_0131)
10000614 (MedDRA 14.1)
L57.0 (ICD-10-CM Version 2010)
702.0 (ICD-9-CM Version 2011)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0718327 (UMLS CUI 2011AA)
386941002 (SNOMED CT 2011_0131)
C0012091 (UMLS CUI 2011AA)
7034005 (SNOMED CT 2011_0131)
MTHU024758 (LOINC Version 232)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
Item
Topical treatment with imiquimod or diclofenac anywhere else on the body within the last 2 months prior to randomisation.
boolean
C0150349 (UMLS CUI 2011AA)
386439008 (SNOMED CT 2011_0131)
C0718327 (UMLS CUI 2011AA)
386941002 (SNOMED CT 2011_0131)
C0012091 (UMLS CUI 2011AA)
7034005 (SNOMED CT 2011_0131)
MTHU024758 (LOINC Version 232)
C1268086 (UMLS CUI 2011AA)
123037004 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
Item
Presence of any histologically confirmed skin tumour in the STA: in situ SCC including Bowen's disease, invasive SCC, basal cell carcinoma, or other malignant tumours.
boolean
C0037286 (UMLS CUI 2011AA)
126488004 (SNOMED CT 2011_0131)
10029098 (MedDRA 14.1)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0444498 (UMLS CUI 2011AA)
264031007 (SNOMED CT 2011_0131)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0006079 (UMLS CUI 2011AA)
84999002 (SNOMED CT 2011_0131)
10006059 (MedDRA 14.1)
D00-D09 (ICD-10-CM Version 2010)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0007137 (UMLS CUI 2011AA)
28899001 (SNOMED CT 2011_0131)
10041823 (MedDRA 14.1)
C0007117 (UMLS CUI 2011AA)
1338007 (SNOMED CT 2011_0131)
10004146 (MedDRA 14.1)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
Item
Any dermatological disease or condition that may exacerbate by treatment with imiquimod or diclofenac (e.g. rosacea, psoriasis, atopic dermatitis).
boolean
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0718327 (UMLS CUI 2011AA)
386941002 (SNOMED CT 2011_0131)
C0012091 (UMLS CUI 2011AA)
7034005 (SNOMED CT 2011_0131)
MTHU024758 (LOINC Version 232)
C0035854 (UMLS CUI 2011AA)
398909004 (SNOMED CT 2011_0131)
10039218 (MedDRA 14.1)
L71.9 (ICD-10-CM Version 2010)
695.3 (ICD-9-CM Version 2011)
C0033860 (UMLS CUI 2011AA)
9014002 (SNOMED CT 2011_0131)
10037153 (MedDRA 14.1)
L40 (ICD-10-CM Version 2010)
C0011615 (UMLS CUI 2011AA)
24079001 (SNOMED CT 2011_0131)
10012438 (MedDRA 14.1)
L20.9 (ICD-10-CM Version 2010)
Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
Item
Any dermatological disease or condition in the STA that causes difficulty with examination (e.g. eczema).
boolean
C0037274 (UMLS CUI 2011AA)
95320005 (SNOMED CT 2011_0131)
10048768, 10040831 (MedDRA 14.1)
MTHU031899 (LOINC Version 232)
C2828392 (UMLS CUI 2011AA)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0678227 (UMLS CUI 2011AA)
23981006 (SNOMED CT 2011_0131)
C1299586 (UMLS CUI 2011AA)
52925006 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0013595 (UMLS CUI 2011AA)
43116000 (SNOMED CT 2011_0131)
10014184 (MedDRA 14.1)
L30.9 (ICD-10-CM Version 2010)
Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
Item
Systemic immunomodulatory treatment such as interferon, azathioprine, cyclosporine, retinoids, any oral or injectable corticosteroids, or inhaled or nasal corticosteroids with dosages of >1200 µg/day beclomethasone or equivalent within 4 weeks before start of study treatment.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL412323 (UMLS CUI 2011AA)
C0021747 (UMLS CUI 2011AA)
49327004 (SNOMED CT 2011_0131)
MTHU021353 (LOINC Version 232)
C0004482 (UMLS CUI 2011AA)
372574004 (SNOMED CT 2011_0131)
MTHU006794 (LOINC Version 232)
C0010592 (UMLS CUI 2011AA)
387467008 (SNOMED CT 2011_0131)
MTHU005140 (LOINC Version 232)
C2267033 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0004905 (UMLS CUI 2011AA)
116574000 (SNOMED CT 2011_0131)
History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
Item
History of any malignant tumour with high tumour burden or any systemic antitumour treatment (incl. radiotherapy).
boolean
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0920425 (UMLS CUI 2011AA)
C0034619 (UMLS CUI 2011AA)
History of any malignant skin tumour having metastasised or where metastasis could be expected.
Item
History of any malignant skin tumour having metastasised or where metastasis could be expected.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007114 (UMLS CUI 2011AA)
372130007 (SNOMED CT 2011_0131)
10040808 (MedDRA 14.1)
C44.9 (ICD-10-CM Version 2010)
C0027627 (UMLS CUI 2011AA)
128462008 (SNOMED CT 2011_0131)
10027449 (MedDRA 14.1)
C1517001 (UMLS CUI 2011AA)
History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
Item
History of severe cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, mental, neurological, or other disease within the last two years.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0007222 (UMLS CUI 2011AA)
105980002 (SNOMED CT 2011_0131)
10007649 (MedDRA 14.1)
429.2 (ICD-9-CM Version 2011)
C0024115 (UMLS CUI 2011AA)
19829001 (SNOMED CT 2011_0131)
10025082 (MedDRA 14.1)
J98.4 (ICD-10-CM Version 2010)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
C0022658 (UMLS CUI 2011AA)
90708001 (SNOMED CT 2011_0131)
10029151 (MedDRA 14.1)
N18.9 (ICD-10-CM Version 2010)
C0017178 (UMLS CUI 2011AA)
119292006 (SNOMED CT 2011_0131)
10017944 (MedDRA 14.1)
C0018939 (UMLS CUI 2011AA)
191124002 (SNOMED CT 2011_0131)
10061590 (MedDRA 14.1)
D75.9 (ICD-10-CM Version 2010)
289.9 (ICD-9-CM Version 2011)
C0014130 (UMLS CUI 2011AA)
362969004 (SNOMED CT 2011_0131)
10014695 (MedDRA 14.1)
MTHU021570 (LOINC Version 232)
E34.9 (ICD-10-CM Version 2010)
259.9 (ICD-9-CM Version 2011)
C0025517 (UMLS CUI 2011AA)
30390004 (SNOMED CT 2011_0131)
10058097 (MedDRA 14.1)
E88.9 (ICD-10-CM Version 2010)
277.9 (ICD-9-CM Version 2011)
C0004936 (UMLS CUI 2011AA)
74732009 (SNOMED CT 2011_0131)
10037174 (MedDRA 14.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
C0027765 (UMLS CUI 2011AA)
118940003 (SNOMED CT 2011_0131)
10029202 (MedDRA 14.1)
G98.8 (ICD-10-CM Version 2010)
349.9 (ICD-9-CM Version 2011)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
Mentally incapacitated patient.
Item
Mentally Disabled Persons
boolean
C0079822 (UMLS CUI 2011AA)
Present or history of drug or alcohol abuse within the last 3 years.
Item
Present or history of drug or alcohol abuse within the last 3 years.
boolean
C0013146 (UMLS CUI 2011AA)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
C0085762 (UMLS CUI 2011AA)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
C1299544 (UMLS CUI 2011AA)
371435006 (SNOMED CT 2011_0131)
C0221628 (UMLS CUI 2011AA)
371434005 (SNOMED CT 2011_0131)
Exposure to an investigational product within the last 3 months.
Item
Exposure to an investigational product within the last 3 months.
boolean
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C1517741 (UMLS CUI 2011AA)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Lack of ability or willingness to give informed consent.
Item
Lack of ability or willingness to give informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Age below 18 years.
Item
Age below 18 years.
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
Item
Lack of willingness to have personal study related data collected, archived or transmitted according to protocol.
boolean
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1709695 (UMLS CUI 2011AA)
C0681884 (UMLS CUI 2011AA)
C0681873 (UMLS CUI 2011AA)
C0525058 (UMLS CUI 2011AA)
Anticipated non-availability for study visits/procedures.
Item
Anticipated non-availability for study visits/procedures.
boolean
C0679106 (UMLS CUI 2011AA)
C0686905 (UMLS CUI 2011AA)
397854000 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C0680734 (UMLS CUI 2011AA)
Vulnerable subjects (such as persons kept in detention).
Item
Vulnerable subjects (such as persons kept in detention).
boolean
C1562367 (UMLS CUI 2011AA)
417430008 (SNOMED CT 2011_0131)
C0680725 (UMLS CUI 2011AA)
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