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NCT00197379 Clinical Trial

The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

Alopecia Clinical Trial

Official title:
The Study for New Effect of Roxithromycin on Androgenetic Alopecia.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00197379
Other study ID # 16-61
Secondary ID
Status Active, not recruiting
Phase N/A
First received September 12, 2005
Last updated July 28, 2010
Start date May 2005
Est. completion date January 2007

Study information
Verified date April 2005
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Androgenetic alopecia

Exclusion Criteria:

- Cicatricial alopecia

- Allergy to roxitromycin

- Children (19years old or younger)

- Pregnant female

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• roxithromycin

Locations
Country Name City State
Japan Department of Dermatology, Hamamatsu University School of Medicine Hamamatsu

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

References & Publications (3)

Ito T, Ito N, Saathoff M, Bettermann A, Takigawa M, Paus R. Interferon-gamma is a potent inducer of catagen-like changes in cultured human anagen hair follicles. Br J Dermatol. 2005 Apr;152(4):623-31. — View Citation

Lindner G, Botchkarev VA, Botchkareva NV, Ling G, van der Veen C, Paus R. Analysis of apoptosis during hair follicle regression (catagen). Am J Pathol. 1997 Dec;151(6):1601-17. — View Citation

Ohshima A, Tokura Y, Wakita H, Furukawa F, Takigawa M. Roxithromycin down-modulates antigen-presenting and interleukin-1 beta-producing abilities of murine Langerhans cells. J Dermatol Sci. 1998 Jul;17(3):214-22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Secondary Pathological study taken from lesional scalp skin. One year
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