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 (FPHL)

Minoxidil in Treatment of Androgenetic Alopecia

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• FPHL

Exclusion Criteria:

• No

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol; Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol	Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol; Other Names: Topical minoxidil 5% with 90% ethanol and 5% propylene glycol
Active Comparator: Topical minoxidil 5% in pure ethanol alone; Group B applied topical minoxidil 5% in pure ethanol alone	Drug: 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 Names: Topical minoxidil 5%
Placebo Comparator: Placebo; Group C applied pure ethanol (placebo)	Other: Placebo (Ethanol); The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Principal Investigator: Mohammed Abu El-Hamd, MD, Faculty of Medicine, Sohag University, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2015
• Primary Completion (Actual): May 30, 2016
• Study Completion (Actual): January 23, 2017

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Female pattern hair loss; Minoxidil.
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Physiological Effects of Drugs; Antihypertensive Agents; Vasodilator Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Ethanol; Minoxidil
• Other Study ID Numbers: 5/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No