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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Zurita Laboratorio Farmaceutico Ltda..
Recruitment status was:  Not yet recruiting
Information provided by:
Zurita Laboratorio Farmaceutico Ltda. Identifier:
First received: December 13, 2010
Last updated: December 14, 2010
Last verified: September 2010

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: Intervention Model: Single Group Assignment
Masking: Single Blind (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)

Resource links provided by NLM:

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 ]
    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


Ages Eligible for Study:   12 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01260571

Contact: Sergio Schalka, Doctor's (11) 36816362

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

Responsible Party: Sergio Schalka, Medicin Skin Institute Identifier: NCT01260571     History of Changes
Other Study ID Numbers: EAA 554-10/v6
Study First Received: December 13, 2010
Last Updated: December 14, 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 processed this record on May 23, 2017