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

Phase 4

Completed

• Conditions: Female Pattern Hair Loss
• Interventions: Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol; Drug: Topical minoxidil 5% in pure ethanol alone; Other: Placebo (Ethanol)

• Registration Number: NCT04090801
• Lead Sponsor: Sohag University

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.

Study Timeline

• Study Start: 2015-05-30
• Primary Completion: 2016-05-30
• Study Completion: 2017-01-23
• Study First Submitted: 2019-08-30
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• FPHL

Exclusion Criteria

• No

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol	Topical minoxidil 5% in 90% ethanol and 5% propylene glycol	Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Topical minoxidil 5% in pure ethanol alone	Topical minoxidil 5% in pure ethanol alone	Group B applied topical minoxidil 5% in pure ethanol alone
Placebo	Placebo (Ethanol)	Group C applied pure ethanol (placebo)

Primary Outcome Measures

Name	Time	Method
Ludwig scale grading system	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).
Trichoscopic examination of the hairs at frontal and occipital regions of the scalp.	0-6 months	It will be evaluated signs of hair changes such as hair diameter diversity.