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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)

Information source: Zurita Laboratorio Farmaceutico Ltda.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment of Acne Vulgaris Grade II in a Short Period of Time.

Intervention: Benzoyl peroxide and sulfur (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Zurita Laboratorio Farmaceutico Ltda.

Overall contact:
Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medcin@medcinonline.com.br

Summary

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.

Clinical Details

Official title: 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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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).

Eligibility

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medcin@medcinonline.com.br

Medcin Instituto da Pele, Osasco, São Paulo 06023-000, Brazil; Not yet recruiting
Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medicin@medicinonline.com.br
Sergio Schalka, Doctor's, Principal Investigator
Additional Information

Starting date: January 2011
Last updated: December 14, 2010

Page last updated: August 23, 2015

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