Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate
This study has been completed.
Sponsor:
Igefarma Laboratorios S.A.
Information provided by:
Igefarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT00838812
First received: February 5, 2009
Last updated: May 24, 2010
Last verified: May 2010
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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 3 |
| 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:
Tretinoin
Clindamycin hydrochloride
Clindamycin phosphate
Clindamycin palmitate hydrochloride
Clindamycin palmitate
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 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 May 19, 2013