Status:
UNKNOWN
Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II
Lead Sponsor:
Zurita Laboratorio Farmaceutico Ltda.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12-35 years
Phase:
PHASE3
Brief 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).
Detailed Description
The acne is a common dermatosis in dermatological practice, affects more than 80% of the population during the second and third decades of life. It is found worldwide, with no evidence of racial or et...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00877409
Start Date
April 1 2009
End Date
July 1 2009
Last Update
April 7 2009
Active Locations (1)
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1
Medcin Instituto da Pele Ltda.
Osasco, São Paulo, Brazil, 06023-000