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The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by Hamamatsu University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00197379
First received: September 12, 2005
Last updated: July 28, 2010
Last verified: April 2005
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Study for New Effect of Roxithromycin on Androgenetic Alopecia.

Resource links provided by NLM:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197379

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

Additional Information:
Hamamatsu University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00197379     History of Changes
Other Study ID Numbers: 16-61
Study First Received: September 12, 2005
Last Updated: July 28, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:
androgenetic alopecia
roxitromycin
apoptosis

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
 Roxithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2012