Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
NCT ID: NCT01655108
Last Updated: 2013-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Saline
Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
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.
Minoxidil
Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Androgenetic Alopecia (female pattern hair loss)
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Brasilia University Hospital
OTHER
Responsible Party
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Izelda Maria Carvalho Costa
Adjunct Professor
Principal Investigators
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Barbara Uzel, M.D
Role: PRINCIPAL_INVESTIGATOR
University of Brasilia
Izelda Costa, Ph.D
Role: STUDY_DIRECTOR
University of Brasilia
Locations
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University of Brasilia
BrasÃlia, Federal District, Brazil
Countries
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Other Identifiers
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HUB-UnB TrichoGroup 1
Identifier Type: -
Identifier Source: org_study_id