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This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.
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 :
Group 1 (Placebo):
30 patients who will have intradermal injections in the scalp of saline 0.9%
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | 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. |
|
| Minoxidil 0.5% /2ml | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minoxidil | Drug | Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in hair density | 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 | Sixteen weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mesotherapy safety | 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 | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Uzel, M.D | University of Brasilia | Principal Investigator |
| Izelda Costa, Ph.D | University of Brasilia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Brasilia | BrasÃlia | Federal District | 71917-720 | Brazil |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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| Saline | Drug | Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |