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

Female Pattern Alopecia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01655108
• Other study ID #: HUB-UnB TrichoGroup 1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 24, 2012
• Last updated: September 23, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Brasilia University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Alopecia

Intervention

Drug:
• Minoxidil
Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
• Saline
Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks

Locations

Country	Name	City	State
Brazil	University of Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes