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)

December 14, 2010 updated by: Zurita Laboratorio Farmaceutico Ltda.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Osasco, São Paulo, Brazil, 06023-000
        • Medcin Instituto Da Pele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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).
Time Frame: 24 hours
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurita Laboratorio Farmaceutico Ltda.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (Estimate)

December 15, 2010

Study Record Updates

Last Update Posted (Estimate)

December 15, 2010

Last Update Submitted That Met QC Criteria

December 14, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAA 554-10/v6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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