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Completed

NCT Number: NCT04090801

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

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.

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Key information

Conditions

Female Pattern Hair Loss

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • FPHL

Exclusion criteria

  • No

Treatment and study plan

Topical minoxidil 5% in 90% ethanol and 5% propylene glycol

Drug

Other names: Topical minoxidil 5% with 90% ethanol and 5% propylene glycol

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.

Other names: Topical minoxidil 5%

Placebo (Ethanol)

Other

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

Primary outcomes

  1. Ludwig scale grading system

    Time frame: 0-6 months

    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).

  2. Trichoscopic examination of the hairs at frontal and occipital regions of the scalp.

    Time frame: 0-6 months

    It will be evaluated signs of hair changes such as hair diameter diversity.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Minoxidil in Treatment of Androgenetic Alopecia

Acronym: FPHL

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 16, 2019
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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