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)
Information source: Zurita Laboratorio Farmaceutico Ltda.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Treatment of Acne Vulgaris Grade II in a Short Period of Time.
Intervention: Benzoyl peroxide and sulfur (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Zurita Laboratorio Farmaceutico Ltda. Overall contact: Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medcin@medcinonline.com.br
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.
Clinical Details
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 design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: 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).
Eligibility
Minimum age: 12 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medcin@medcinonline.com.br
Medcin Instituto da Pele, Osasco, São Paulo 06023-000, Brazil; Not yet recruiting Sergio Schalka, Doctor's, Phone: (11) 36816362, Email: medicin@medicinonline.com.br Sergio Schalka, Doctor's, Principal Investigator
Additional Information
Starting date: January 2011
Last updated: December 14, 2010
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