The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

• Sponsor: Hamamatsu University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00197379
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 1

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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 1, 2005
• Anticipated Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

1. Pathological study taken from lesional scalp skin. [One year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Hamamatsu University School of Medicine

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00197379
• Other Study ID Numbers: 16-61
• First Posted: Sep 20, 2005
• Last Update Posted: Jul 29, 2010
• Last Verified: Apr 1, 2005

• Keywords provided by , ,: androgenetic alopecia; roxitromycin; apoptosis
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Roxithromycin

Study Results

No Results Posted as of Jul 29, 2010