Acne vulgaris MedDRA version: 9.1 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Interventions
Product Name: CD5789
Product Code: CD5789
Pharmaceutical Form: Gel
Current Sponsor code: CD5789
Other descriptive name: CD5789
Concentration unit: % percent
Concentration type: equal
Concentration num
Sponsors
GALDERMA R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subject aged from 18 to 35 years 2. The subject has a skin phototype of I to IV on Fitzpatrick’s scale 3. The subject has medical diagnosis of acne vulgaris on face 4. The subject has, on the face, at least 15 inflammatory lesions and 25 non-inflammatory lesions but no more than 2 nodules 5. The Subject has a severity grade 2 through 5 according to the Leeds Revised Acne Grading System 6. If the subject is a female of childbearing potential*, she agrees to use highly effective contraceptive method listed above for the duration of the study and one month after the last product application : - strict abstinence, - bilateral tubal ligation, - combined oral contraceptives for at least 1 month prior to Screening visit, - implanted or injectable contraceptives on a stable dose for at least 1 month prior to Screening visit, - hormonal intra-uterine device (IUD), - partner with a vasectomy for at least 3 months prior to Screening visit. For all this method (except the strict abstinence), the association with the use of condom is mandatory during the study and one month after the last product application. * A female of non-childbearing potential is a postmenopausal female (absence of menstrual bleeding for 1 year and without any other medical reason), or a female presenting with a hysterectomy or bilateral ovariectomy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has severe forms of acne (acne conglobata, acne fulminans) or secondary acne form (chloracne, drug-induced acne, etc.) 2. The number of inflammatory or non inflammatory lesions on half-face is greater than twice the number on the other half-face 3. The subject has an underlying disease, which in the investigator’s opinion, may confound the study assessments (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy on acne lesions and the safety of CD5789 0.01% and 0.005% after four weeks of once daily application compared to its gel vehicle using clinical and photographic evaluations.;Secondary Objective: To evaluate the efficacy of CD5789 on Propionibacterium acnes.;Primary end point(s): Total acne lesion count and percent reduction at end of treatment (D27) evaluated clinically. | — |
Countries
France
Outcome results
None listed