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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)

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Benzoyl peroxide and sulfur
Sponsored by
Zurita Laboratorio Farmaceutico Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment of Acne Vulgaris Grade II in a Short Period of Time. focused on measuring blackheads and pimples, Acne vulgaris grade II

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medcin Instituto da Pele

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Benzoyl Peroxide and Sulfur

Arm Description

Topical Medications containing benzoyl peroxide and sulfur

Outcomes

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).
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2010
Last Updated
December 14, 2010
Sponsor
Zurita Laboratorio Farmaceutico Ltda.
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1. Study Identification

Unique Protocol Identification Number
NCT01260571
Brief 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)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zurita Laboratorio Farmaceutico Ltda.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment of Acne Vulgaris Grade II in a Short Period of Time.
Keywords
blackheads and pimples, Acne vulgaris grade II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Benzoyl Peroxide and Sulfur
Arm Type
Experimental
Arm Description
Topical Medications containing benzoyl peroxide and sulfur
Intervention Type
Drug
Intervention Name(s)
Benzoyl peroxide and sulfur
Intervention Description
topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours
Primary Outcome Measure Information:
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).
Description
Clinical evolution of the target lesions for each experimental time regarding the parameters of reddening, size and general appearance of the lesion.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Schalka, Doctor's
Phone
(11) 36816362
Email
medcin@medcinonline.com.br
Facility Information:
Facility Name
Medcin Instituto da Pele
City
Osasco
State/Province
São Paulo
ZIP/Postal Code
06023-000
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Schalka, Doctor's
Phone
(11) 36816362
Email
medicin@medicinonline.com.br
First Name & Middle Initial & Last Name & Degree
Sergio Schalka, Doctor's

12. IPD Sharing Statement

Learn more about this trial

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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