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)

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

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01260571
• Other study ID #: EAA 554-10/v6
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 13, 2010
• Last updated: December 14, 2010
• Start date: January 2011
• Est. completion date: March 2011

Study information

• Verified date: September 2010
• Source: Zurita Laboratorio Farmaceutico Ltda.
• Contact: Sergio Schalka, Doctor's
• Phone: (11) 36816362
• Email: medcin[@]medcinonline.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Benzoyl peroxide and sulfur
topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours

Locations

Country	Name	City	State
Brazil	Medcin Instituto da Pele	Osasco	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Zurita Laboratorio Farmaceutico Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No