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

NCT04090801 | Completed Phase 4

• 1 other identifier: 5/2015
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Female Pattern Hair Loss

Keywords

Female pattern hair loss; Minoxidil.

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

ACTIVE COMPARATOR

Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol

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

Topical minoxidil 5% in pure ethanol alone

ACTIVE COMPARATOR

Group B applied topical minoxidil 5% in pure ethanol alone

Drug: Topical minoxidil 5% in pure ethanol alone

Placebo

PLACEBO COMPARATOR

Group C applied pure ethanol (placebo)

Other: Placebo (Ethanol)

Interventions

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

Also known as: Topical minoxidil 5% with 90% ethanol and 5% propylene glycol

Topical minoxidil 5% in 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.

Also known as: Topical minoxidil 5%

Topical minoxidil 5% in pure ethanol alone

Placebo (Ethanol) OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• FPHL

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Interventions

Minoxidil; Ethanol; Propylene Glycol

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Alcohols; Organic Chemicals; Propylene Glycols; Glycols

Study Officials

• Mohammed Abu El-Hamd, MD

  Faculty of Medicine, Sohag University, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 16, 2019
• Study Start: May 30, 2015
• Primary Completion: May 30, 2016
• Study Completion: January 23, 2017
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share