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

NCT00877409 | Unknown Phase 3

• 1 other identifier: EAA461-08/v8
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Acne Vulgaris

Keywords

Acnase; Acne Vulgaris; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Average clinical development of target lesions of the groups for each experimental time.

  12 weeks

Secondary Outcomes (3)

• Clinical evolution of the acne through the counting of inflammatory and non - inflammatory lesions.

  12 weeks

• Evaluation of oily skin through the clinical evaluation with four-point scale (absent, mild, moderate, intense)

  12 weeks

• Observation of occurrence and intensity of clinical parameters erythema, scaling, itching and burning through the clinical evaluation with four-point scale (absent, mild, moderate, severe).

  12 weeks

Study Arms (2)

Acnase

ACTIVE COMPARATOR

Drug: Benzoyl Peroxide 5% and Sulphur 2%

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle of Acnase

Interventions

Benzoyl Peroxide 5% and Sulphur 2% DRUG

The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.

Also known as: Acnase

Acnase

Vehicle of Acnase DRUG

The product will be applied topically forming a thin layer, 1 time a day (at night) throughout the area affected by lesions.

Also known as: Control, Vehicle, Placebo

Vehicle

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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..;

Sponsors & Collaborators

• Zurita Laboratorio Farmaceutico Ltda.: lead

Study Sites (1)

Medcin Instituto da Pele Ltda.

Osasco, São Paulo, 06023-000, Brazil

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Benzoyl Peroxide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Sérgio Schalka, MD

  Medcin Instituto da Pele Ltda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Schalka, MD

CONTACT

55-11-36546362; sergio@medcinonline.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

BR (1)