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| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | October 30, 2007 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
The hair elongation after 1 week of application. Cosmetical improvement. Evaluation by dermoscopy | ||||
| Change History | Complete list of historical versions of study NCT00197379 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pathological study taken from lesional scalp skin. [ Time Frame: One year ] | ||||
| Original Secondary Outcome Measures ICMJE |
Pathological study taken from lesional scalp skin. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia | ||||
| Official Title ICMJE | The Study for New Effect of Roxithromycin on Androgenetic Alopecia. | ||||
| Brief Summary | The purpose of this study is exploiting the new drugs for androgenetic alopecia because there are still no effective and safe topical drug for androgenetic alopecia. Roxithomycin is one of the macrolide antibiotics that has immunomodulatory effects. We firstly found that roxithromycin increases the rate of murine and human hair follicle elongation in vitro. Therefore, we apply this drug on this disease therapy. |
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| Detailed Description | The topical therapy for androgenetic alopecia is still not enough to improve cosmetically. Thereforem we try to find new effective and safe topical therapy for this disease. Roxithromycin has not only antibacterial action but also immunomodulatory and anti-inflamatory potency. For example, roxitromycin inhibits T cell responces to mitogens and production of cytokines, IL-2 and IL-5. We firstly found that roxitromycin increased human and murine hair elongation in vitro to inhibit apoptosis of hair bulb. Then, we wish to apply roxithromycin on the therapy for androgenetic alopecia. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Alopecia | ||||
| Intervention ICMJE | Drug: roxithromycin | ||||
| 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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | January 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00197379 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 16-61 | ||||
| Study Sponsor ICMJE | Hamamatsu University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hamamatsu University | ||||
| Verification Date | April 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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