Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)

Study Overview
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Brief Summary
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Sixty two subjects will take part in this study. The study is unic arm. The subjects used the product once and will be evaluated in the regression of pimples in the times 0,4,6,8 and 24 hours after application. A follow-up visit will be made 24 hours after initiation of treatment.

Official Title
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Clinical Study to Evaluate the Efficacy of Topical Medications Containing Benzoyl Peroxide and Sulfur in the Regression in the Short Time (24 Hours) of Moderate Acne Vulgaris Grade II (Pimples)

Conditions
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Treatment of Acne Vulgaris Grade II in a Short Period of Time.

Intervention / Treatment
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* Drug: Benzoyl peroxide and sulfur


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of both sexes aged to 12 years to 35 years Oily skin prone to acne Presence of at least three inflammatory lesions, diagnosed as grade II acne vulgaris. Sign the informed Consent Form Comply the requirements and attend to study visits Exclusion Criteria: Pregnancy (need for urinary pregnancy test for women of childbearing age) Lactation Presence of acne conglobata and nodulocystic Pathologies associated hormonal (thyroid diseases, ovaries micropolycystic) Drug use systemic corticosteroids, anticonvulsants and / or new drugs for up to one month before to selection. History of atopy or allergic cutaneous History of hypersensitivity to benzoyl peroxide and sulfur Beginning or ending the use of contraceptives (for females) Intense sun exposure until one month before the evaluation

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benzoyl Peroxide and Sulfur<br>Topical Medications containing benzoyl peroxide and sulfur | Drug: Benzoyl peroxide and sulfur<br>* topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical study to evaluate the efficacy of topical medications containing benzoyl peroxide and sulfur in the regression in the short time (24 hours) of moderate acne vulgaris grade II (pimples). | Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blackheads and pimples, Acne vulgaris grade II