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)

NCT ID: NCT01260571

Last Updated: 2010-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment of Acne Vulgaris Grade II in a Short Period of Time.

Keywords

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blackheads and pimples Acne vulgaris grade II

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Benzoyl Peroxide and Sulfur

Topical Medications containing benzoyl peroxide and sulfur

Group Type EXPERIMENTAL

Benzoyl peroxide and sulfur

Intervention Type DRUG

topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours

Interventions

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Benzoyl peroxide and sulfur

topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zurita Laboratorio Farmaceutico Ltda.

INDUSTRY

Sponsor Role lead

Responsible Party

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Medicin Skin Institute

Locations

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Medcin Instituto da Pele

Osasco, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Sergio Schalka, Doctor's

Role: CONTACT

Phone: (11) 36816362

Email: [email protected]

Facility Contacts

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Sergio Schalka, Doctor's

Role: primary

Other Identifiers

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EAA 554-10/v6

Identifier Type: -

Identifier Source: org_study_id