Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
This trial is active, not recruiting.
|Condition||female pattern alopecia|
|Sponsor||Brasilia University Hospital|
|Start date||March 2012|
|End date||October 2013|
|Trial size||60 participants|
|Trial identifier||NCT01655108, HUB-UnB TrichoGroup 1|
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
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Increase in hair density
time frame: Sixteen weeks
time frame: six months
Female participants from 18 years up to 65 years old.
Inclusion Criteria: - Women from 18 to 65 years old - Androgenetic Alopecia (female pattern hair loss) Exclusion Criteria: - patients with alopecia areata or cicatricial alopecia - pregnancy and breastfeeding - have undergone any specific treatment in the last 06 months - use of drugs with anti-androgenic properties - patients with signs or symptoms of hyper-androgynism
|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|
|Principal investigator||Barbara Uzel, M.D|
|Description||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 : 1. Group 1 (Placebo): 30 patients who will have intradermal injections in the scalp of saline 0.9% 2. 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.|
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