Acne Vulgaris Treatment MedDRA version: 8.1 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Interventions
Product Name: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel
Product Code: Adapalene/Benzoyl Peroxide Gel
Pharmaceutical Form: Gel
INN or Proposed INN: Adapalene
CAS Number: 106685-40-9
Current Sponsor code
Sponsors
Galderma Research & Development Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects 12 years of age or older. 2. A clinical diagnosis of acne vulgaris with facial involvement. 3. A minimum of 20 but not more than 50 Inflammatory lesions (papules and pustules) on the face (excluding the nose) and not more than one acne nodule. 4. A minimum of 30 but not more than 100 Noninflammatory lesions (open comedones and closed comedones) on the face (excluding the nose). 5. A score of 3 (Moderate) on the Investigator’s Global Assessment Scale. 6. Females of childbearing potential (including pre-menstrual subjects) with a negative urine pregnancy test (UPT) or females of non-childbearing potential, defined as post menopausal (absence of menstrual bleeding for 1 year prior to enrollment), hysterectomy or bilateral oophorectomy. Are the trial subjects under 18? yes 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than one acne nodule. 2. Any acne cyst. 3. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks;Secondary Objective: ;Primary end point(s): • Success Rate is defined as the percentage of subjects rated Clear or Almost Clear on the Investigator’s Global Assessment (IGA) at Week 12, Last Observation Carried Forward (LOCF), Intent to Treat Population (ITT) • Change in Lesion Counts: - Change in Inflammatory Lesion Counts from Baseline to Week 12 (LOCF, ITT) - Change in Noninflammatory Lesion Counts from Baseline to Week 12 (LOCF, ITT) | — |
Countries
Hungary
Outcome results
None listed