The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia - Full Text View

Sponsor:	Hamamatsu University
Information provided by:	Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00197379

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:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	The Study for New Effect of Roxithromycin on Androgenetic Alopecia.

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Hair Problems

Drug Information available for: Roxithromycin

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:

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.

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.

Study ID Numbers:	16-61
Study First Received:	September 12, 2005
Last Updated:	October 30, 2007
ClinicalTrials.gov Identifier:	NCT00197379 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hamamatsu University:

androgenetic alopecia, roxitromycin, apoptosis

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Hair Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Hypotrichosis

Skin Diseases
Roxithromycin
Therapeutic Uses
Alopecia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009