Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate - Full Text View

Sponsor:	Igefarma Laboratorios S.A.
Information provided by:	Igefarma Laboratorios S.A.
ClinicalTrials.gov Identifier:	NCT00838812

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: application of the topic gel	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Tretinoin

U.S. FDA Resources

Further study details as provided by Igefarma Laboratorios S.A.:

Primary Outcome Measures:

Evaluation of the efficacy, through number of lesions, and tolerability of the product. [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Enrollment:	154
Study Start Date:	March 2009
Study Completion Date:	April 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838812

Locations

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

Sponsors and Collaborators

Igefarma Laboratorios S.A.

More Information

No publications provided

Responsible Party:	Dra. Rosa Maria Scavarelli, I
ClinicalTrials.gov Identifier:	NCT00838812 History of Changes
Other Study ID Numbers:	IGF 03-42008
Study First Received:	February 5, 2009
Last Updated:	May 24, 2010
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Igefarma Laboratorios S.A.:

clindamycin
tretinoin
acne vulgaris
Acne vulgaris mild to moderate

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Clindamycin
Clindamycin-2-phosphate
Tretinoin
Protein Synthesis Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012