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

NCT ID: NCT04090801

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-30
• Study Completion Date: 2017-01-23

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.

Conditions

Female Pattern Hair Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Topical minoxidil 5% in pure ethanol alone

Group B applied topical minoxidil 5% in pure ethanol alone

Group Type: ACTIVE_COMPARATOR

Topical minoxidil 5% in pure ethanol alone

Intervention Type: DRUG

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

Placebo

Group C applied pure ethanol (placebo)

Group Type: PLACEBO_COMPARATOR

Placebo (Ethanol)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Placebo (Ethanol)

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

Intervention Type: OTHER

Other Intervention Names

Topical minoxidil 5% with 90% ethanol and 5% propylene glycol; Topical minoxidil 5%

Eligibility Criteria

Inclusion Criteria

• FPHL

Exclusion Criteria

• No

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Abu El-Hamd

Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Abu El-Hamd, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Sohag University, Egypt.

Other Identifiers

5/2015

Identifier Type: -

Identifier Source: org_study_id