Acne Vulgaris
Conditions
Keywords
Adapalene, Benzoyl Peroxide, Acne Vulgaris
Brief summary
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel in the treatment of acne vulgaris. The safety will also be evaluated.
Interventions
DRUGAdapalene-BPO Gel
Apply 1 gram of the investigational drug every night on whole face.
Sponsors
Galderma Brasil Ltda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Subjects, aged 12 to 35 years inclusive, with moderate to severe facial acne vulgaris (described scale score of 3 or 4), * Subjects with a minimum of 20 and a maximum of 50 Inflammatory Lesions (papules and pustules) on the face, excluding the nose, * Subjects with a minimum of 30 and a maximum of 100 Non-Inflammatory Lesions (open comedones and closed comedones) on the face, excluding the nose, * Female Subjects of childbearing potential with a negative urine pregnancy test at the Baseline visit and must practice a highly 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, * 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, * Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Subjects under the majority must sign an assent-to-participate form to participate in the study and they must have one parent or guardian read and sign the Informed Consent form prior to any study related procedure, * Subjects willing and capable of cooperating to the extend and degree required by the protocol.
Exclusion criteria
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment, * Female Subjects who are pregnant, nursing or planning a pregnancy during the study, * Subjects with more than 1 nodule or cyst on the face * Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), * Subjects with known or suspected allergy to one of the investigational products (see package insert and/or investigator brochure), * Subjects who have pathological conditions photosensitive porphyria, SLE, LED, solar polymorphous eruption, actinic prurigo, solar urticaria, etc. * Subjects with a beard or other facial hair that might interfere with study assessments, * Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc...) * Female subjects with a history of hormonal changes. * Subjects with skin condition or disease requiring topical or systemic therapy, which interferes with the investigational product or that may directly affect the evaluation criteria: * Topical treatment for acne in the past two weeks. * Anti-inflammatory topic in the last two weeks. * Use of topical corticosteroids on the face in the last four weeks. * Anti-inflammatory systemic (hormonal or not) in the last four weeks. * Use of systemic corticosteroids in the last four weeks. * Systemic antibiotics in the last four weeks (excluding penicillins). * Systemic retinoids in the last six months. * Other systemic anti-acne the last four weeks. * Anticonceptional oral used exclusively for the control of acne in the past six months. * Cosmetic procedures such as facials, peels, exfoliation, extraction of comedones, application of LED, laser or pulsed light in the last two weeks. * Cosmetic procedures such as PDT in the last four weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation | Week 12 | Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy evaluation | Week 1 | Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 1. |
| Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 2. Secondary efficacy evaluation | Week 4 | Changing from Baseline in Total Lesion count (Non-Inflammatory and Inflammatory lesions) in Week 4. |
| Safety evaluation | Week 1 | Local tolerability scores - Erythema, Scaling, Dryness, Stinging/Burning at each study visit. |
Countries
Brazil
Outcome results
None listed