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

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

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

Study Overview

• Status: Unknown
• Conditions: Female Pattern Alopecia
• Intervention / Treatment: Drug: Saline; Drug: Minoxidil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesotherapy safety	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	six months

Collaborators and Investigators

• Sponsor: Brasilia University Hospital
• Investigators: Principal Investigator: Barbara Uzel, M.D, University of Brasilia; Study Director: Izelda Costa, Ph.D, University of Brasilia

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 31, 2012
• First Posted (Estimate): August 1, 2012

Study Record Updates

• Last Update Posted (Estimate): September 25, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Androgenetic Alopecia; Minoxidil; Mesotherapy; Trichogram
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: HUB-UnB TrichoGroup 1