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

NCT ID: NCT00838812

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clindamicin and tretinoin gel

Group Type: OTHER

application of the topic gel

Intervention Type: DRUG

Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

Interventions

application of the topic gel

Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Igefarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

I

Locations

Lal Clinica

Valinhos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

IGF 03-42008

Identifier Type: -

Identifier Source: org_study_id