Overview

This trial is active, not recruiting.

Condition female pattern alopecia
Treatments minoxidil, saline
Phase phase 3
Sponsor Brasilia University Hospital
Start date March 2012
End date October 2013
Trial size 60 participants
Trial identifier NCT01655108, HUB-UnB TrichoGroup 1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
saline
Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
(Active Comparator)
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
Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks

Primary Outcomes

Measure
Increase in hair density
time frame: Sixteen weeks

Secondary Outcomes

Measure
Mesotherapy safety
time frame: six months

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Brasilia University Hospital.