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The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2005 by Hamamatsu University.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: September 20, 2005
Last Update Posted: July 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hamamatsu University
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 Intervention
Alopecia Drug: roxithromycin

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Hamamatsu University:

Secondary Outcome Measures:
  • Pathological study taken from lesional scalp skin. [ Time Frame: One year ]

Estimated Enrollment: 20
Study Start Date: May 2005
Estimated Study Completion Date: January 2007
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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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Androgenetic alopecia

Exclusion Criteria:

  • Cicatricial alopecia
  • Allergy to roxitromycin
  • Children (19years old or younger)
  • Pregnant female
  Contacts and Locations
Information from the National Library of Medicine

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

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

Additional Information:
ClinicalTrials.gov Identifier: NCT00197379     History of Changes
Other Study ID Numbers: 16-61
First Submitted: September 12, 2005
First Posted: September 20, 2005
Last Update Posted: July 29, 2010
Last Verified: April 2005

Keywords provided by Hamamatsu University:
androgenetic alopecia

Additional relevant MeSH terms:
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Anti-Infective Agents