Comparison of Topical Minoxidil 5% in Ethanol Plus Propylene Glycol Versus Minoxidil 5% in Ethanol Alone in Treatment of Women With Female Pattern Hair Loss

Study Overview
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Brief Summary
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The study will be included 60 women with FPHL. The diagnosis of FPHL will be established by clinical (Ludwig classification) and trichoscopic evaluation of frontal and occipital regions of the scalp.

Detailed Description
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Enrolled women will be randomly assigned into 3 treatment groups: group A will apply topical minoxidil 5% in 90% ethanol and 5% propylene glycol, group B will apply topical minoxidil 5% in pure ethanol alone and group C will apply pure ethanol (placebo) twice daily. The treatment will be continued for six months with regular visits at 3 months intervals. The medications will be provided in bottles which were identical in shape and color, and were coded by a third party. Both patients and investigator will be blinded to the medication. Disclosure of the codes will be done, by a third party, at the end of the study.

Official Title
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Minoxidil in Treatment of Androgenetic Alopecia

Conditions
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Female Pattern Hair Loss

Intervention / Treatment
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* Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
* Drug: Topical minoxidil 5% in pure ethanol alone
* Other: Placebo (Ethanol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FPHL Exclusion Criteria: No

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be to compare the efficacy of topical minoxidil 5% solution in ethanol plus 5% propylene glycol (PG), as a vehicle, versus 5% minoxidil in ethanol alone in treatment of women with FPHL.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol<br>Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol | Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol<br> <br> * Other names: Topical minoxidil 5% with 90% ethanol and 5% propylene glycol;|
| Active Comparator: Topical minoxidil 5% in pure ethanol alone<br>Group B applied topical minoxidil 5% in pure ethanol alone | Drug: Topical minoxidil 5% in pure ethanol alone<br>* The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.<br>* Other names: Topical minoxidil 5%;|
| Placebo Comparator: Placebo<br>Group C applied pure ethanol (placebo) | Other: Placebo (Ethanol)<br>* The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ludwig scale grading system | The 3 grades will be defined. Grade 1, (Thinning of hair is seen mainly over the anterior part of the crown with minimal widening of the parting width). Grade 2, (Thinning of the crown becomes more evident because of an increase in the number of thin and short hairs). Grade 3, (The crown becomes almost total bald, but the frontal hair line is still maintained). | 0-6 months | 
| Trichoscopic examination of the hairs at frontal and occipital regions of the scalp. | It will be evaluated signs of hair changes such as hair diameter diversity. | 0-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minoxidil., Female pattern hair loss