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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

Minoxidil in Treatment of Androgenetic Alopecia

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04090801
Acronym
FPHL
Enrollment
60
Registered
2019-09-16
Start date
2015-05-30
Completion date
2017-01-23
Last updated
2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Pattern Hair Loss

Keywords

Female pattern hair loss, Minoxidil.

Brief summary

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

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.

Interventions

DRUGTopical minoxidil 5% in 90% ethanol and 5% propylene glycol
DRUGTopical minoxidil 5% in pure ethanol alone

The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.

OTHERPlacebo (Ethanol)

The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* FPHL

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Ludwig scale grading system0-6 monthsThe 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).
Trichoscopic examination of the hairs at frontal and occipital regions of the scalp.0-6 monthsIt will be evaluated signs of hair changes such as hair diameter diversity.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026