Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.
- Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks.
- One group will receive 0.5%/2ml minoxidil application and a control group will receive application of placebo (saline 0.9%).
- Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before and 08 weeks after treatment as a method objective evaluation of the response
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||BLIND RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MESOTHERAPY MINOXIDIL HAIR WITH 0.5% / 2ML VERSUS PLACEBO IN THE TREATMENT OF FEMALE ANDROGENETIC ALOPECIA|
- Increase in hair density [ Time Frame: Sixteen weeks ] [ Designated as safety issue: No ]Six weeks after the last session of mesotherapy patients will be subjected to control examinations to evaluation of results. Scalp biopsy to determine the terminal-vellus ratio, trichogram to assess the percentage of anagen hair, telogen and dystrophic and Trichoscan will be performed to see if there was improvement in hair density
- Mesotherapy safety [ Time Frame: six months ] [ Designated as safety issue: Yes ]
In each session of mesotherapy, blood pressure and cardiac frequency at baseline and 10 min after application of the drug will be measured to assess the safety profile of the solution of minoxidil to 0.5% when injected intradermally.
Any adverse effect reported will be recorded on specific clinical form
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Saline
After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the placebo group, thirty women will be subjected to intradermal application (mesotherapy) of saline; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results.
Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
Active Comparator: Minoxidil 0.5% /2ml
After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the drug active group, thirty women will be subjected to intradermal application (mesotherapy) of minoxidil 0.5%/2ml; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results.
Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
This is a trial that aims to analyze the efficacy and safety of mesotherapy with minoxidil 0,5% versus placebo for androgenetic alopecia in female patients.
The patients and the investigators who analyzes complementary exams are blind.
Clinical criteria, photo, 4mm biopsia, trichogram and trichoscopy are perfomed before patients are randomized into two arms :
Group 1 (Placebo):
30 patients who will have intradermal injections in the scalp of saline 0.9%
Group 2 (Active Drug):
30 patients who will receive intradermal injections in the scalp with minoxidil 0.5%/2ml
Eight weeks after the last session patients will be recruited for repeat the exams and perform a self-assessment of both the effect on hair growth and the effect on hair loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655108
|University of Brasilia|
|Brasilia, Distrito Federal, Brazil, 71917-720|
|Principal Investigator:||Barbara Uzel, M.D||University of Brasilia|
|Study Director:||Izelda Costa, Ph.D||University of Brasilia|