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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
Information provided by:
Hamamatsu University

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date July 29, 2010
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
The hair elongation after 1 week of application. Cosmetical improvement. Evaluation by dermoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Pathological study taken from lesional scalp skin. [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Pathological study taken from lesional scalp skin.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia
Intervention  ICMJE Drug: roxithromycin
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Androgenetic alopecia

Exclusion Criteria:

  • Cicatricial alopecia
  • Allergy to roxitromycin
  • Children (19years old or younger)
  • Pregnant female
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00197379
Other Study ID Numbers  ICMJE 16-61
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hamamatsu University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Masahiro Takigawa, M.D. Hamamatsu University
PRS Account Hamamatsu University
Verification Date April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP