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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)

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ClinicalTrials.gov Identifier: NCT04090801
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Mohammed Abu El-Hamd, 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.

Condition or disease Intervention/treatment Phase
Female Pattern Hair Loss Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycol Drug: Topical minoxidil 5% in pure ethanol alone Other: Placebo (Ethanol) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Minoxidil in Treatment of Androgenetic Alopecia
Actual Study Start Date : May 30, 2015
Actual Primary Completion Date : May 30, 2016
Actual Study Completion Date : January 23, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Ludwig scale grading system [ Time Frame: 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).

  2. Trichoscopic examination of the hairs at frontal and occipital regions of the scalp. [ Time Frame: 0-6 months ]
    It will be evaluated signs of hair changes such as hair diameter diversity.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • FPHL

Exclusion Criteria:

  • No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090801


Sponsors and Collaborators
Sohag University
Investigators
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Principal Investigator: Mohammed Abu El-Hamd, MD Faculty of Medicine, Sohag University, Egypt.

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Responsible Party: Mohammed Abu El-Hamd, Assistant Professor of Dermatology, Venereology and Andrology Department, Faculty of Medicine, Sohag University, Egypt., Sohag University
ClinicalTrials.gov Identifier: NCT04090801     History of Changes
Other Study ID Numbers: 5/2015
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Mohammed Abu El-Hamd, Sohag University:
Female pattern hair loss
Minoxidil.
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Ethanol
Minoxidil
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antihypertensive Agents
Vasodilator Agents