Acne vulgaris with a high level of P. Acnes on the face (obeserved under wood's lamp) MedDRA version: 12.0 Level: LLT Classification code 10000519 Term: Acne vulgaris
Conditions
Interventions
Trade Name: Epiduo® Gel
Product Name: Epiduo® Gel
Pharmaceutical Form: Gel
INN or Proposed INN: ADAPALENE
CAS Number: 106685409
Concentration unit: % percent
Concentration type: equal
Concentration nu
Sponsors
Galderma research & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female Subjects of any race, aged 18 years or more, 2. Subjects with facial acne, 3. Subjects with high levels of P. acnes counts on the forehead (score of 3 according to a 4-point scale with 0 = no fluorescence and 3 = strong level of fluorescence) under Wood’s lamp, 4. Subjects with a minimum of 10 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, 5. Subjects with a minimum of 10 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, 6. Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice an effective method of contraception during the study: oral/systemic [injectable, patch…] contraception (must have been on a stable dose for 3 months prior to study entry), Intrauterine Device, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy, 7. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, bilateral tubal ligation, or bilateral ovariectomy, secondary infertility and sterility are not required to have a UPT at the beginning of the study, 8. Subjects have to read and sign the approved Informed Consent form prior to any participation in the study, 9. Subjects willing and capable of complying with requirements of the protocol visits and procedures. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with more than 1 nodule or cyst on the face, 2. Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), 3. Female Subjects who are pregnant, nursing or planning a pregnancy during the study, 4. Subjects with a wash-out period for topical treatment on the face less than (see table below): - Corticosteroids, Antibiotics, Antibacterials, Antiseptics, Retinoids, other Anti- Inflammatory treatments or other acne treatments 2 weeks - Phototherapy devices for acne and cosmetic procedures (i.e., facials, peels, comedone extraction) 1 week 5. Subjects with a wash-out period for systemic treatment less than (see table below): • Corticosteroids, Antibiotics 4 weeks • Other acne treatments (including isotretinoin) 6 months • Ciproterone acetate 6 months • Spironolactone 3 months 6. Subjects with a condition or who are in a situation which, in the Investigator’s opinion, may put the Subjects at risk may confound the study results, or may interfere with the Subjects’ participation in the study, 7. Subjects who are at risk in terms of precautions, warnings, and contraindications (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD), 8. Subjects with known or suspected allergy to one of the test products (see Summary of Medicinal Product Characteristics (SmPC) / Investigational Medicinal Product Dossier (IMPD), 9. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, 10. Adult Subjects under guardianship, hospitalized Subjects in a public or private institution for a reason other than the research, and Subjects deprived of freedom, 11. Subjects with a beard or other facial hair that might interfere with study assessments, 12. Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel in order to assess if the retinoid present in Epiduo® (Adapalene) increases the antimicrobial efficacy of Benzoyl Peroxide 2.5% Gel;Secondary Objective: ;Primary end point(s): Change from Baseline in P. acnes counts and P. acnes resistant to erythromycin and clindamycin counts at each evaluation time for : - Superficial skin flora (Week 2, Week 6 and Week 12 visits); - Follicular skin flora (Week 12 visit | — |
Countries
Poland
Outcome results
None listed