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

Acne Vulgaris Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838812
• Other study ID #: IGF 03-42008
• Status: Completed
• Phase: Phase 3
• First received: February 5, 2009
• Last updated: May 24, 2010
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Igefarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• application of the topic gel
Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

Locations

Country	Name	City	State
Brazil	Lal Clinica	Valinhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Igefarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the efficacy, through number of lesions, and tolerability of the product.		three months	Yes