Back to resultsThe Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
Primary Purpose
Alopecia
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
roxithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia focused on measuring androgenetic alopecia, roxitromycin, apoptosis
Eligibility Criteria
Inclusion Criteria: Androgenetic alopecia Exclusion Criteria: Cicatricial alopecia Allergy to roxitromycin Children (19years old or younger) Pregnant female
Sites / Locations
- Department of Dermatology, Hamamatsu University School of Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Pathological study taken from lesional scalp skin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00197379
Brief Title
The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
Official Title
The Study for New Effect of Roxithromycin on Androgenetic Alopecia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hamamatsu University
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia
Keywords
androgenetic alopecia, roxitromycin, apoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
roxithromycin
Secondary Outcome Measure Information:
Title
Pathological study taken from lesional scalp skin.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Androgenetic alopecia
Exclusion Criteria:
Cicatricial alopecia
Allergy to roxitromycin
Children (19years old or younger)
Pregnant female
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahiro Takigawa, M.D.
Organizational Affiliation
Hamamatsu University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Dermatology, Hamamatsu University School of Medicine
City
Hamamatsu
ZIP/Postal Code
431-3192
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
9697050
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. doi: 10.1016/s0923-1811(98)00017-6.
Results Reference
background
PubMed Identifier
15840090
Citation
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.
Results Reference
background
PubMed Identifier
9403711
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.
Results Reference
background
Links:
URL
http://www.hama-med.ac.jp/
Description
Hamamatsu University School of Medicine
Learn more about this trial
The Effect of 0.5% Roxithromycin Lotion for Androgenetic Alopecia
We'll reach out to this number within 24 hrs