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

This study is currently recruiting participants.
Verified July 2012 by Brasilia University Hospital
Sponsor:
Information provided by (Responsible Party):
Izelda Maria Carvalho Costa, Brasilia University Hospital
ClinicalTrials.gov Identifier:
NCT01655108
First received: July 24, 2012
Last updated: July 31, 2012
Last verified: July 2012
History of Changes

July 24, 2012
July 31, 2012
March 2012
December 2012   (final data collection date for primary outcome measure)
Increase in hair density [ Time Frame: Two months ] [ Designated as safety issue: No ]
Two months 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
Same as current
Complete list of historical versions of study NCT01655108 on ClinicalTrials.gov Archive Site
Mesotherapy safety [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

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
Same as current
 
 
 
Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
ESTUDO COMPARATIVO RANDOMIZADO DUPLO CEGO PARA AVALIAR A EFICÁCIA E SEGURANÇA DA MESOTERAPIA CAPILAR COM MINOXIDIL 0,5% / 2ML VERSUS PLACEBO NO TRATAMENTO DA ALOPECIA ANDROGENETICA FEMININA

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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Female Pattern Alopecia
  • Drug: Minoxidil
    Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
  • Drug: Saline
    Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
  • 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.
    Intervention: Drug: Saline
  • 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.
    Intervention: Drug: Minoxidil
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years
No
Contact: Barbara Uzel, M.D 556178132043 barbara.uzel@gmail.com
Contact: Barbara Uzel, M.D 556181930468 barbara.uzel@gmail.com
Brazil
 
NCT01655108
HUB-UnB TrichoGroup 1
No
Izelda Maria Carvalho Costa, Brasilia University Hospital
Brasilia University Hospital
 
Principal Investigator: Barbara Uzel, M.D University of Brasilia
Study Director: Izelda Costa, Ph.D University of Brasilia
Brasilia University Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP