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

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ClinicalTrials.gov Identifier: NCT01655108
Recruitment Status : Unknown
Verified September 2013 by Izelda Maria Carvalho Costa, Brasilia University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : August 1, 2012
Last Update Posted : September 25, 2013
Sponsor:
Information provided by (Responsible Party):

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%

    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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil
U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655108


Locations
Brazil
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
More Information

Responsible Party: Izelda Maria Carvalho Costa, Adjunct Professor, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT01655108     History of Changes
Other Study ID Numbers: HUB-UnB TrichoGroup 1
First Posted: August 1, 2012    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by Izelda Maria Carvalho Costa, Brasilia University Hospital:
Androgenetic Alopecia
Mesotherapy
Minoxidil
Trichogram

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents