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

Overview:

Status: Completed
Study State Date: March 2009
Primary Completion Date: Actual January 2010
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: Phase 3

Sponsor(s):

Igefarma Laboratorios S.A.

Information By: Igefarma Laboratorios S.A.
Trial Identifier: NCT00838812
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.

Description: 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.

Eligibility:

Accepts Healthy Volunteers?: Accepts Healthy Volunteers
Enrollment: 154 Actual
Minimum Age: 12 Years
Maximum Age: N/A
Gender(s): Both
Additional 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.

Conditions:
Acne Vulgaris

Interventions:
Drug: application of the topic gel

Primary Outcome Measures:

Evaluation of the efficacy, through number of lesions, and tolerability of the product.
Time Frame: three months
Safety Issue: Yes

Patient Groups:

Assigned Interventions:

clindamicin and tretinoin gel: Other

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

Location & Contacts:

Responsible Party:
I (Dra. Rosa Maria Scavarelli)

Study Locations:
+ Show All 1 Study Locations

Brazil
Lal Clinica
Valinhos, Brazil

Latest Clinical
Trials News

Diabetes Clinical Trials search for new treatments and cures
03/14/2010

There are a number of clinical trials underway to find effective treatments for diabetes, including new drugs, surgery and even transplantation.

Feeling Depressed? A clinical trial might help.
03/07/2010

There are several current and ongoing trials of interventions for major depressive disorder, which is characterized by a disabling combination of symptoms causing severe disruption to the sufferer's ability to carry out routine functions and tasks of daily life.

The State of Constipation Clinical Trials
02/28/2010

Constipation is a illness where the bowels cannot move waste material out of the body in a normal manner. There are various clinical trials recruiting participants to study the effectiveness of various treatments.