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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 16, 2005 | ||||||||
| Last Updated Date | January 31, 2006 | ||||||||
| Start Date ICMJE | August 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Long-term efficacy | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00240513 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Relapse rate | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study to Compare the Acne Relapse Rate of Oral Minocycline to Oral Minocycline in Combination With Topical Tretinoin, Followed by Topical Tretinoin Alone | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Acne Vulgaris | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | December 2006 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00240513 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 2004-03 | ||||||||
| Study Sponsor ICMJE | Derm Research @ 888 Inc. | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Derm Research @ 888 Inc. | ||||||||
| Verification Date | October 2005 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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