Acne vulgaris MedDRA version: 19.0 Level: LLT Classification code 10000519 Term: Acne vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Soolantra® cream 10 mg/g (1%)
Product Name: Soolantra® cream 10 mg/g (1%)
Product Code: CD5024
Pharmaceutical Form: Cream
INN or Proposed INN: IVERMECTIN
CAS Number: 70288-86-7
Current Spo
Sponsors
Galderma R&D SNC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is a male or a female aged from 18 to 35 years old before screening visit. 2. The subject has a medical diagnosis of acne vulgaris defined by : 2.1. at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) (Screening and Baseline) 2.2. symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side 3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study 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 60 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 an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening). 2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. 3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator’s Brochure/Product label). 4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective of the study is to evaluate the safety of CD5024 1% cream applied once daily 5 days a week over a 6-week treatment period compared to its vehicle in adult patients suffering from acne vulgaris.;Main Objective: The primary objective of the study is to evaluate the efficacy of CD5024 1% cream applied once daily 5 days a week over a 6-week treatment period compared to its vehicle in adult patients suffering from acne vulgaris.;Primary end point(s): Efficacy: Inflammatory acne lesion count per half face;Timepoint(s) of evaluation of this end point: at day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Inflammatory acne lesion count and percent reduction per half face - Total acne lesion count and percent reduction per half face - Non-inflammatory lesion count and percent reduction per half face;Timepoint(s) of evaluation of this end point: At each evaluation visit | — |
Countries
Canada, France, Germany
Contacts
Public ContactCTA Coordinator
Galderma R&D SNC
Outcome results
None listed