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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01655108

Enrollment

Registered

2012-08-01

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2013-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Pattern Alopecia

Keywords

Androgenetic Alopecia, Mesotherapy, Minoxidil, Trichogram

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

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.

Interventions

DRUGMinoxidil

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

DRUGSaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026