- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00197379
The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
July 28, 2010 updated by: Hamamatsu University
The Study for New Effect of Roxithromycin on Androgenetic Alopecia.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamamatsu, Japan, 431-3192
- Department of Dermatology, Hamamatsu University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Androgenetic alopecia
Exclusion Criteria:
- Cicatricial alopecia
- Allergy to roxitromycin
- Children (19years old or younger)
- Pregnant female
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pathological study taken from lesional scalp skin.
Time Frame: One year
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Masahiro Takigawa, M.D., Hamamatsu University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ohshima A, Tokura Y, Wakita H, Furukawa F, Takigawa M. Roxithromycin down-modulates antigen-presenting and interleukin-1 beta-producing abilities of murine Langerhans cells. J Dermatol Sci. 1998 Jul;17(3):214-22. doi: 10.1016/s0923-1811(98)00017-6.
- Ito T, Ito N, Saathoff M, Bettermann A, Takigawa M, Paus R. Interferon-gamma is a potent inducer of catagen-like changes in cultured human anagen hair follicles. Br J Dermatol. 2005 Apr;152(4):623-31. doi: 10.1111/j.1365-2133.2005.06453.x.
- Lindner G, Botchkarev VA, Botchkareva NV, Ling G, van der Veen C, Paus R. Analysis of apoptosis during hair follicle regression (catagen). Am J Pathol. 1997 Dec;151(6):1601-17.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion
December 7, 2022
Study Completion (Anticipated)
January 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
July 29, 2010
Last Update Submitted That Met QC Criteria
July 28, 2010
Last Verified
April 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-61
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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