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

Female Pattern Hair Loss Clinical Trial

— FPHL  

Official title:

Minoxidil in Treatment of Androgenetic Alopecia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04090801
• Other study ID #: 5/2015
• Status: Completed
• Phase: Phase 4
• Start date: May 30, 2015
• Est. completion date: January 23, 2017

Study information

• Verified date: September 2019
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 23, 2017
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• FPHL

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Female Pattern Hair Loss

Intervention

Drug:
• Topical minoxidil 5% in 90% ethanol and 5% propylene glycol

• Topical minoxidil 5% in pure ethanol alone
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.

Other:
• Placebo (Ethanol)
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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