Acne Vulgaris | Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II
Acne Vulgaris research study
What is the primary objective of this study?
The objective of this study is to establish the safety in use of the topical drug Acnase Creme and its effectiveness in treatment of acne grade I (comedones) and II (comedones, papules, pustules).
Who is eligible to participate?
Inclusion Criteria: - Age: 12 to 35 years; - Oily skin with tendency to acne; - Presence of non-inflammatory lesions and inflammatory, acne vulgaris diagnosed as grade I or II, as the following: I) Comedones - only comedones; II) Papulopustular - comedones, papules and pustules; III) Nodulocystic - comedones, papules, pustules, nodules and cysts; IV) Conglobates - severe acne, usually affects other areas of the body, out of preference, giving comedones, papules, pustules, abscesses, confluent nodules, cysts and scars. - Agreement in compliance with the procedures of the trial and attend the clinic on certain days and times for medical evaluations and scores of injuries acne; - Signing of the Term of Free and Informed Consent and agreement of the lowest in the case of patients between 12 and 17 years. Exclusion Criteria: - Pregnancy (pregnancy test by urinary indication to women voluntary of childbearing age); - Nursing; - Nodulocystic and Conglobates acne; - Conditions associated hormone (tireoid disease, micropolicysts ovaries, adrenal or pituitary disorders); - Drug use systemic corticosteroids, anticonvulsants, photo-sensibility and / or new drugs for up to 01 months before the selection; - Use of topical therapy, systemic or physical (cleaning of the skin) for the treatment of acne at least 01 months before the selection; - History of atopic or allergic skin; - History of hypersensitivity to Benzoyl peroxide or sulfur; - Skin Conditions active (and / or spread) that may interfere with the outcome of the study; - Beginning or end-use of contraceptives; (for females) - Sunlight intense exposure until 01 months before the assessment; - Aesthetic treatments, skin up to 01 months before the selection; - Use of specific oily cosmetic for skin / acne and makeup, facial moisturizing, etc..; - Use of the drug Acnase prior to inclusion in the study.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Benzoyl Peroxide 5% and Sulphur 2%The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
Drug:Vehicle of AcnaseThe product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2009
Completed Date: July 2009
Phase: Phase 3
Primary Outcome: Average clinical development of target lesions of the groups for each experimental time.
Secondary Outcome: Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions.
Study sponsors, principal investigator, and references
Principal Investigator: Sérgio Schalka, MD
Lead Sponsor: Zurita Laboratorio Farmaceutico Ltda.