Clinical trial: Safety and Efficacy Study of Acnase Creme in the Treatment of Acne Vulgaris I and II (NCT00877409)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers.  The rashes are mildly itchy. The patient has no other medical conditions and takes no medications.  Vital signs are normal.  On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer.  There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance.

Patient description (patient's own words): I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction.

Does the patient match the trial criteria? Entailment