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

NCT01655108 | Unknown Phase 3

• 1 other identifier: HUB-UnB TrichoGroup 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Female Pattern Alopecia

Keywords

Androgenetic Alopecia; Mesotherapy; Minoxidil; Trichogram

Outcome Measures

Primary Outcomes (1)

• Increase in hair density

  Six weeks 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

  Sixteen weeks

Secondary Outcomes (1)

• Mesotherapy safety

  six months

Study Arms (2)

Saline

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.

Drug: Saline

Minoxidil 0.5% /2ml

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.

Drug: Minoxidil

Interventions

Minoxidil DRUG

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

Minoxidil 0.5% /2ml

Saline DRUG

Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 18 to 65 years old
• Androgenetic Alopecia (female pattern hair loss)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

University of Brasilia

Brasília, Federal District, 71917-720, Brazil

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Sodium Chloride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Barbara Uzel, M.D

  University of Brasilia

  PRINCIPAL INVESTIGATOR

• Izelda Costa, Ph.D

  University of Brasilia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: August 1, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 25, 2013

Record last verified: 2013-09

Locations

BR (1)