Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients - Full Text View

Purpose

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

Condition	Intervention	Phase
Female Pattern Alopecia	Drug: Minoxidil Drug: Saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	ESTUDO COMPARATIVO RANDOMIZADO DUPLO CEGO PARA AVALIAR A EFICÁCIA E SEGURANÇA DA MESOTERAPIA CAPILAR COM MINOXIDIL 0,5% / 2ML VERSUS PLACEBO NO TRATAMENTO DA ALOPECIA ANDROGENETICA FEMININA

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: Minoxidil

U.S. FDA Resources

Further study details as provided by Brasilia University Hospital:

Primary Outcome Measures:

Increase in hair density [ Time Frame: Two months ] [ Designated as safety issue: No ]
Two months 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

Secondary Outcome Measures:

Mesotherapy safety [ Time Frame: One Year ] [ 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

Estimated Enrollment:	60
Study Start Date:	March 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: Saline 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.	Drug: Minoxidil Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks

Arms

Assigned Interventions

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.

Drug: Saline

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.

Drug: Minoxidil

Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655108

Locations

Brazil
University of Brasilia
Brasilia, Distrito Federal, Brazil, 71917-720

Sponsors and Collaborators

Brasilia University Hospital

Investigators

Principal Investigator:	Barbara Uzel, M.D	University of Brasilia
Study Director:	Izelda Costa, Ph.D	University of Brasilia

More Information

No publications provided

Responsible Party:	Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital
ClinicalTrials.gov Identifier:	NCT01655108 History of Changes
Other Study ID Numbers:	HUB-UnB TrichoGroup 1
Study First Received:	July 24, 2012
Last Updated:	February 8, 2013
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Brasilia University Hospital:

Androgenetic Alopecia
Mesotherapy
Minoxidil
Trichogram

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013