Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
Information source: Brasilia University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Female Pattern Alopecia
Intervention: Minoxidil (Drug); Saline (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Brasilia University Hospital Official(s) and/or principal investigator(s): Barbara Uzel, M.D, Principal Investigator, Affiliation: University of Brasilia Izelda Costa, Ph.D, Study Director, Affiliation: University of Brasilia
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Increase in hair density
Secondary outcome: Mesotherapy safety
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University of Brasilia, Brasilia, Distrito Federal 71917-720, Brazil
Additional Information
Starting date: March 2012
Last updated: September 23, 2013
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