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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)

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ClinicalTrials.gov Identifier: NCT01260571
Recruitment Status : Unknown
Verified September 2010 by Zurita Laboratorio Farmaceutico Ltda..
Recruitment status was:  Not yet recruiting
First Posted : December 15, 2010
Last Update Posted : December 15, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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)
Study Start Date : January 2011
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sergio Schalka, Medicin Skin Institute
ClinicalTrials.gov Identifier: NCT01260571     History of Changes
Other Study ID Numbers: EAA 554-10/v6
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: December 15, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents