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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical minoxidil 5% in 90% ethanol and 5% propylene glycol | Active Comparator | Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol |
|
| Topical minoxidil 5% in pure ethanol alone | Active Comparator | Group B applied topical minoxidil 5% in pure ethanol alone |
|
| Placebo | Placebo Comparator | Group C applied pure ethanol (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical minoxidil 5% in 90% ethanol and 5% propylene glycol | Drug |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Abu El-Hamd, MD | Faculty of Medicine, Sohag University, Egypt. | Principal Investigator |
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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.
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The medications will be provided in bottles which will be identical in shape and color, and will be 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.
| Topical minoxidil 5% in pure ethanol alone | Drug | The treatment will be continued twice daily.for six months with regular visits at 3 months intervals. |
|
|
| Placebo (Ethanol) | Other | The treatment will be continued twice daily.for six months with regular visits at 3 months intervals. |
|
| ID | Term |
|---|---|
| D008914 | Minoxidil |
| D000431 | Ethanol |
| D019946 | Propylene Glycol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
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