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

• Sponsor: Brasilia University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01655108
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Female Pattern Alopecia	Drug: Minoxidil; Drug: Saline	Phase 3

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%

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2012
• Anticipated Primary Completion Date: Oct 1, 2013
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Increase in hair density [Sixteen weeks]

   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

Secondary Outcome Measures

1. Mesotherapy safety [six months]

   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

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital
• ClinicalTrials.gov Identifier: NCT01655108
• Other Study ID Numbers: HUB-UnB TrichoGroup 1
• First Posted: Aug 1, 2012
• Last Update Posted: Sep 25, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital: Androgenetic Alopecia; Mesotherapy; Minoxidil; Trichogram
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Minoxidil

Study Results

No Results Posted as of Sep 25, 2013