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

Brasilia University Hospital

Status and phase: Unknown; Phase 3

Conditions: Female Pattern Alopecia

Treatments: Drug: Minoxidil; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01655108

HUB-UnB TrichoGroup 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Minoxidil 0.5% /2ml

Active Comparator group

Description:

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.

Treatment:

Drug: Minoxidil