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 12 Years to 45 Years
Item
age 12 Years to 45 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Males or females 12 to 45 years of age, inclusive, in good general health.
Item
Males or females 12 to 45 years of age, inclusive, in good general health.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0031206 (UMLS CUI 2011AA)
405153007 (SNOMED CT 2011_0131)
Clinical diagnosis of acne vulgaris
Item
Clinical diagnosis of acne vulgaris
boolean
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
Capable of understanding and willing to provide signed and dated written voluntary informed consent
Item
Capable of understanding and willing to provide signed and dated written voluntary informed consent
boolean
C0021430 (UMLS CUI 2011AA)
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
Item
Female subjects of childbearing potential must have a negative pregnancy test at baseline. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0427780 (UMLS CUI 2011AA)
250425007 (SNOMED CT 2011_0131)
10036574 (MedDRA 14.1)
C1442488 (UMLS CUI 2011AA)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
Item
Subjects who have been treated with estrogens, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to the first dose of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study.
boolean
CL415147 (UMLS CUI 2011AA)
C0014939 (UMLS CUI 2011AA)
41598000, 61946003 (SNOMED CT 2011_0131)
MTHU003480 (LOINC Version 232)
C0002844 (UMLS CUI 2011AA)
66349002 (SNOMED CT 2011_0131)
C0002842 (UMLS CUI 2011AA)
346324007 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
C1524004 (UMLS CUI 2011AA)
C1516879 (UMLS CUI 2011AA)
The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Item
The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0680734 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Female subjects who are pregnant, trying to become pregnant, or who are lactating.
Item
Female subjects who are pregnant, trying to become pregnant, or who are lactating.
boolean
C0086287 (UMLS CUI 2011AA)
248152002 (SNOMED CT 2011_0131)
F (HL7 V3 2006_05)
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C2828358 (UMLS CUI 2011AA)
C0032992 (UMLS CUI 2011AA)
169565003 (SNOMED CT 2011_0131)
Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
Item
Any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases or diseases of the facial skin other than acne vulgaris.
boolean
C1442488 (UMLS CUI 2011AA)
C0031809 (UMLS CUI 2011AA)
5880005 (SNOMED CT 2011_0131)
10034986 (MedDRA 14.1)
MTHU028014 (LOINC Version 232)
89.7 (ICD-9-CM Version 2011)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0222084 (UMLS CUI 2011AA)
73897004 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
Facial hair that may obscure the accurate assessment of acne grade.
Item
Facial hair that may obscure the accurate assessment of acne grade.
boolean
C0221980 (UMLS CUI 2011AA)
62961004 (SNOMED CT 2011_0131)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C0582103 (UMLS CUI 2011AA)
225886003 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
Item
History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
boolean
C0678202 (UMLS CUI 2011AA)
10038280 (MedDRA 14.1)
K50.90 (ICD-10-CM Version 2010)
555 (ICD-9-CM Version 2011)
C0021390 (UMLS CUI 2011AA)
24526004 (SNOMED CT 2011_0131)
10021972 (MedDRA 14.1)
C0302596 (UMLS CUI 2011AA)
64766004 (SNOMED CT 2011_0131)
10009900 (MedDRA 14.1)
K51 (ICD-10-CM Version 2010)
556 (ICD-9-CM Version 2011)
C1257843 (UMLS CUI 2011AA)
397683000 (SNOMED CT 2011_0131)
10037128 (MedDRA 14.1)
A04.7 (ICD-10-CM Version 2010)
C0401151 (UMLS CUI 2011AA)
236071009 (SNOMED CT 2011_0131)
10066556 (MedDRA 14.1)
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0085819 (UMLS CUI 2011AA)
397696004 (SNOMED CT 2011_0131)
10052815 (MedDRA 14.1)
Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
Item
Used topical antibiotics on the face or systemic antibiotics within the past 2 and 4 weeks, respectively.
boolean
C1522168 (UMLS CUI 2011AA)
6064005 (SNOMED CT 2011_0131)
TOPICAL (HL7 V3 2006_05)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
Item
Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
boolean
C0304604 (UMLS CUI 2011AA)
331645009 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used systemic retinoids within the past 6 months.
Item
Used systemic retinoids within the past 6 months.
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C2267033 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
Item
Using drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
boolean
C0162713 (UMLS CUI 2011AA)
108817007 (SNOMED CT 2011_0131)
C0541746 (UMLS CUI 2011AA)
MTHU003336 (LOINC Version 232)
C0039644 (UMLS CUI 2011AA)
66261008 (SNOMED CT 2011_0131)
MTHU008490 (LOINC Version 232)
C0949665 (UMLS CUI 2011AA)
C0031436 (UMLS CUI 2011AA)
372839006 (SNOMED CT 2011_0131)
C0038760 (UMLS CUI 2011AA)
387406002 (SNOMED CT 2011_0131)
MTHU007722 (LOINC Version 232)
CL420107 (UMLS CUI 2011AA)
C0023693 (UMLS CUI 2011AA)
56242006 (SNOMED CT 2011_0131)
C0040539 (UMLS CUI 2011AA)
Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
Item
Using neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
boolean
C0027866 (UMLS CUI 2011AA)
87586001 (SNOMED CT 2011_0131)
C0008947 (UMLS CUI 2011AA)
58883005 (SNOMED CT 2011_0131)
MTHU006899 (LOINC Version 232)
Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
Item
Used topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, salicylates, sulfacetamide sodium and derivatives, glycolic acid) within the past 2 weeks.
boolean
C0360289 (UMLS CUI 2011AA)
350088003 (SNOMED CT 2011_0131)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C2267033 (UMLS CUI 2011AA)
C0052761 (UMLS CUI 2011AA)
108908008 (SNOMED CT 2011_0131)
C0073085 (UMLS CUI 2011AA)
411296008 (SNOMED CT 2011_0131)
C0036075 (UMLS CUI 2011AA)
255637000 (SNOMED CT 2011_0131)
C0282356 (UMLS CUI 2011AA)
108867000 (SNOMED CT 2011_0131)
C0243072 (UMLS CUI 2011AA)
C0220840 (UMLS CUI 2011AA)
115383003 (SNOMED CT 2011_0131)
MTHU009348 (LOINC Version 232)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Used any investigational therapy within 4 weeks of study day 1.
Item
Used any investigational therapy within 4 weeks of study day 1.
boolean
C0949266 (UMLS CUI 2011AA)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C2348558 (UMLS CUI 2011AA)
Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
Item
Using the following types of facial products: astringents, toners, abradants, facials, peels containing glycolic or other acids, masks, washes or soaps containing BPO, sulfacetamide sodium or salicylic acid, non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or alpha- or beta-hydroxy acids.
boolean
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C1514468 (UMLS CUI 2011AA)
C0004110 (UMLS CUI 2011AA)
60533005 (SNOMED CT 2011_0131)
C0022585 (UMLS CUI 2011AA)
373478008 (SNOMED CT 2011_0131)
C0220840 (UMLS CUI 2011AA)
115383003 (SNOMED CT 2011_0131)
MTHU009348 (LOINC Version 232)
C0001128 (UMLS CUI 2011AA)
34957004 (SNOMED CT 2011_0131)
C0441648 (UMLS CUI 2011AA)
C0037392 (UMLS CUI 2011AA)
25780000 (SNOMED CT 2011_0131)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C0282356 (UMLS CUI 2011AA)
108867000 (SNOMED CT 2011_0131)
C0036079 (UMLS CUI 2011AA)
387253001 (SNOMED CT 2011_0131)
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C0724557 (UMLS CUI 2011AA)
C0455079 (UMLS CUI 2011AA)
225130001 (SNOMED CT 2011_0131)
C0087161 (UMLS CUI 2011AA)
82156005 (SNOMED CT 2011_0131)
C0772110 (UMLS CUI 2011AA)
C0439096 (UMLS CUI 2011AA)
260989008 (SNOMED CT 2011_0131)
C0020317 (UMLS CUI 2011AA)
Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments
Item
Using medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins such as vitamin D, vitamin A, and vitamins B2, B6, and B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin, and phenobarbital) as these may impact efficacy assessments
boolean
C0013227 (UMLS CUI 2011AA)
C1444749 (UMLS CUI 2011AA)
410661009 (SNOMED CT 2011_0131)
C0001144 (UMLS CUI 2011AA)
88616000 (SNOMED CT 2011_0131)
10000519 (MedDRA 14.1)
L70.0 (ICD-10-CM Version 2010)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0042866 (UMLS CUI 2011AA)
30178006 (SNOMED CT 2011_0131)
C0042839 (UMLS CUI 2011AA)
82622003 (SNOMED CT 2011_0131)
MTHU005041 (LOINC Version 232)
C0373720 (UMLS CUI 2011AA)
10058767 (MedDRA 14.1)
C0087162 (UMLS CUI 2011AA)
259662009 (SNOMED CT 2011_0131)
C0042845 (UMLS CUI 2011AA)
81064004 (SNOMED CT 2011_0131)
C0018546 (UMLS CUI 2011AA)
386837002 (SNOMED CT 2011_0131)
MTHU005005 (LOINC Version 232)
C0018544 (UMLS CUI 2011AA)
28227002 (SNOMED CT 2011_0131)
C0021966 (UMLS CUI 2011AA)
42146005 (SNOMED CT 2011_0131)
MTHU020182 (LOINC Version 232)
C0006222 (UMLS CUI 2011AA)
16624005 (SNOMED CT 2011_0131)
MTHU005164 (LOINC Version 232)
C0023870 (UMLS CUI 2011AA)
85899009 (SNOMED CT 2011_0131)
MTHU004197 (LOINC Version 232)
C0020208 (UMLS CUI 2011AA)
372659008 (SNOMED CT 2011_0131)
C0031412 (UMLS CUI 2011AA)
51073002 (SNOMED CT 2011_0131)
MTHU003431 (LOINC Version 232)
Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
Item
Have had a facial procedure (chemical or laser peel, microdermabrasion, artificial ultraviolet [UV] therapy) performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks.
boolean
C0015450 (UMLS CUI 2011AA)
89545001 (SNOMED CT 2011_0131)
MTHU003030 (LOINC Version 232)
C2700391 (UMLS CUI 2011AA)
C0191589 (UMLS CUI 2011AA)
22132000 (SNOMED CT 2011_0131)
C0023089 (UMLS CUI 2011AA)
122456005 (SNOMED CT 2011_0131)
C0191587 (UMLS CUI 2011AA)
59601001 (SNOMED CT 2011_0131)
C2004457 (UMLS CUI 2011AA)
71967004 (SNOMED CT 2011_0131)
C0041626 (UMLS CUI 2011AA)
363695005 (SNOMED CT 2011_0131)
10046850 (MedDRA 14.1)
99.82 (ICD-9-CM Version 2011)
C1444637 (UMLS CUI 2011AA)
410513005 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
Item
Have a known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, BPO, or excipients of the study medication.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0023726 (UMLS CUI 2011AA)
372677003 (SNOMED CT 2011_0131)
MTHU008097 (LOINC Version 232)
C0165631 (UMLS CUI 2011AA)
386934008 (SNOMED CT 2011_0131)
C0008947 (UMLS CUI 2011AA)
58883005 (SNOMED CT 2011_0131)
MTHU006899 (LOINC Version 232)
C0005088 (UMLS CUI 2011AA)
354053005 (SNOMED CT 2011_0131)
C0015237 (UMLS CUI 2011AA)
360215002 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
Item
Employees of a clinical research organization involved in the study, or Stiefel Laboratories, or an immediate family member (partner, offspring, parents, siblings, or sibling's offspring) of an employee.
boolean
C0599987 (UMLS CUI 2011AA)
224528001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0683939 (UMLS CUI 2011AA)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0086282 (UMLS CUI 2011AA)
303071001 (SNOMED CT 2011_0131)
FAMMEMB (HL7 V3 2006_05)
Have a member of the same household in this trial.
Item
Have a member of the same household in this trial.
boolean
C0680022 (UMLS CUI 2011AA)
394852005 (SNOMED CT 2011_0131)
C0445247 (UMLS CUI 2011AA)
262126009 (SNOMED CT 2011_0131)
C0020052 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
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