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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

Page last updated: August 23, 2015

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