We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

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.
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

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

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

Layout table for location information
Department of Dermatology, Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192
Sponsors and Collaborators
Hamamatsu University
Layout table for investigator information
Study Chair: Masahiro Takigawa, M.D. Hamamatsu University
Additional Information:
Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Anti-Infective Agents