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

Condition(s) targeted: Acne Vulgaris

Intervention: application of the topic gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Igefarma Laboratorios S.A.

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.

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.

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

Primary outcome: Evaluation of the efficacy, through number of lesions, and tolerability of the product.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Lal Clinica, Valinhos, São Paulo 13276-245, Brazil

Starting date: March 2009
Last updated: May 24, 2010