Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II

• Status: Unknown status
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zurita Laboratorio Farmaceutico Ltda.
• Treatments: Benzoyl Peroxide

Criteria

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.