Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate

May 24, 2010 updated by: Igefarma Laboratorios S.A.

Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.

The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Valinhos, São Paulo, Brazil, 13276-245
        • LAL Clínica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals of both sexes with age greater than or equal to 12 years

  • Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.

    • Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
    • Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
  • Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
  • Be able to properly follow the determinations of the Protocol.
  • Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
  • Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
  • Be mentally able to provide consent and be fulfilling all the requirements of the study.

Exclusion Criteria:

  • Pregnant women or in periods of lactation.
  • Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
  • Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
  • Clinical evidence or history of immunodeficiency.
  • Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
  • Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
  • Prior use of systemic retinoid.
  • Presence of acne medication and/or cosmetic.
  • History of systemic metabolic disorder that can interfere with the integrity of the skin.
  • History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
  • History of joy to any of the components of the formula (active principle or carrier).
  • History of abuse of alcohol and/or illegal drugs.
  • History of non-adherence to medical treatment earlier.
  • Any clinical observation made by the investigator that prohibits participation in the study of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: clindamicin and tretinoin gel
Drug: application of the topic gel
Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the efficacy, through number of lesions, and tolerability of the product.
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igefarma Laboratorios S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

May 25, 2010

Last Update Submitted That Met QC Criteria

May 24, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGF 03-42008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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