The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia

• ClinicalTrials.gov Identifier: NCT00197379
• Recruitment Status: Unknown
• First Posted: September 20, 2005
• Last Update Posted: July 29, 2010
• Sponsor: Hamamatsu University
• Information provided by: Hamamatsu University

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 20, 2005
• Last Update Posted Date: July 29, 2010
• Study Start Date: May 2005
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures (submitted: September 12, 2005): The hair elongation after 1 week of application. Cosmetical improvement. Evaluation by dermoscopy
• Current Secondary Outcome Measures (submitted: October 30, 2007): Pathological study taken from lesional scalp skin. [ Time Frame: One year ]
• Original Secondary Outcome Measures (submitted: September 12, 2005): Pathological study taken from lesional scalp skin.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
• Official Title: The Study for New Effect of Roxithromycin on Androgenetic Alopecia.
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Alopecia
• Intervention: Drug: roxithromycin
• Study Arms: Not Provided

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. doi: 10.1016/s0923-1811(98)00017-6.
• 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. doi: 10.1111/j.1365-2133.2005.06453.x.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 12, 2005): 20
• Original Enrollment: Same as current
• Estimated Study Completion Date: January 2007
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Androgenetic alopecia

Exclusion Criteria:

• Cicatricial alopecia
• Allergy to roxitromycin
• Children (19years old or younger)
• Pregnant female

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00197379
• Other Study ID Numbers: 16-61
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Hamamatsu University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Masahiro Takigawa, M.D.; Hamamatsu University

• PRS Account: Hamamatsu University
• Verification Date: April 2005