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The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT00197379
Recruitment Status : Unknown
Verified April 2005 by Hamamatsu University.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : July 29, 2010
Sponsor:
Information provided by:
Hamamatsu University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alopecia Drug: roxithromycin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study for New Effect of Roxithromycin on Androgenetic Alopecia.
Study Start Date : May 2005
Estimated Study Completion Date : January 2007

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Arms and Interventions
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Outcome Measures
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Secondary Outcome Measures :
  1. Pathological study taken from lesional scalp skin. [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Androgenetic alopecia

Exclusion Criteria:

  • Cicatricial alopecia
  • Allergy to roxitromycin
  • Children (19years old or younger)
  • Pregnant female
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197379


Locations
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Japan
Department of Dermatology, Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Investigators
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Study Chair: Masahiro Takigawa, M.D. Hamamatsu University
More Information
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Additional Information:

Publications:

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ClinicalTrials.gov Identifier: NCT00197379    
Other Study ID Numbers: 16-61
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: April 2005
Keywords provided by Hamamatsu University:
androgenetic alopecia
roxitromycin
apoptosis
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
 Pathological Conditions, Anatomical
Roxithromycin
Anti-Bacterial Agents
Anti-Infective Agents