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| Sponsors and Collaborators: |
Derm Research @ 888 Inc. Investigator initiated study Medication provided by Stiefel Canada. |
|---|---|
| Information provided by: | Derm Research @ 888 Inc. |
| ClinicalTrials.gov Identifier: | NCT00240513 |
Purpose
The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.
Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.
| Condition | Intervention | Phase |
|---|---|---|
|
Acne Vulgaris |
Drug: Minocycline Drug: Minocycline + Tretinoin 0.01% |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Study to Compare the Acne Relapse Rate After a 3-Mo Course of Oral Minocycline, to a 3-Mo Course of Oral Minocycline in Combination With a Daily Dose of Topical Tretinoin 0.01% Followed by 3 Mo of Topical Tretinoin Alone |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | December 2006 |
Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.
Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.
The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Frances Maddin, MA | 604-873-4049 | trials@dermatologyresearch.com |
| Contact: Selena Roy, RN | 604-873-4049 | selena@acne.ca |
| Canada, British Columbia | |
| DermResearch @ 888 Inc | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 3Y1 | |
| Principal Investigator: Richard Thomas, MD, FRCP(C) | |
| Sub-Investigator: Charles Morton, MD FRCP(C) | |
| Principal Investigator: | Richard Thomas, MD, FRCP(C) | DermResearch @ 888 Inc. |
More Information
| Study ID Numbers: | 2004-03 |
| Study First Received: | October 16, 2005 |
| Last Updated: | January 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00240513 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Acne |
|
Keratolytic Agents Anti-Infective Agents Anti-Bacterial Agents Exanthema Minocycline Facial Dermatoses |
Facies Skin Diseases Tretinoin Sebaceous Gland Diseases Acne Vulgaris |
|
Anti-Infective Agents Minocycline Facial Dermatoses Skin Diseases Antineoplastic Agents Sebaceous Gland Diseases Acne Vulgaris |
Pharmacologic Actions Keratolytic Agents Anti-Bacterial Agents Acneiform Eruptions Therapeutic Uses Tretinoin Dermatologic Agents |
