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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Zurita Laboratorio Farmaceutico Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Zurita Laboratorio Farmaceutico Ltda.
ClinicalTrials.gov Identifier:
NCT01260571
First received: December 13, 2010
Last updated: December 14, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Treatment of Acne Vulgaris Grade II in a Short Period of Time.
 Drug: Benzoyl peroxide and sulfur
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Acne
U.S. FDA Resources

Further study details as provided by Zurita Laboratorio Farmaceutico Ltda.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.


Estimated Enrollment: 62
Study Start Date: January 2011
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260571

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

Locations
Brazil
Medcin Instituto da Pele Not yet recruiting
Osasco, São Paulo, Brazil, 06023-000
Contact: Sergio Schalka, Doctor's     (11) 36816362     medicin@medicinonline.com.br    
Principal Investigator: Sergio Schalka, Doctor's            
Sponsors and Collaborators
Zurita Laboratorio Farmaceutico Ltda.
  More Information

No publications provided

Responsible Party: Sergio Schalka, Medicin Skin Institute
ClinicalTrials.gov Identifier: NCT01260571     History of Changes
Other Study ID Numbers: EAA 554-10/v6
Study First Received: December 13, 2010
Last Updated: December 14, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by Zurita Laboratorio Farmaceutico Ltda.:
blackheads and pimples
Acne vulgaris grade II

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
 Benzoyl Peroxide
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013