- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090801
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Other Names:
|
Active Comparator: Topical minoxidil 5% in pure ethanol alone
Group B applied 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:
|
Placebo Comparator: Placebo
Group C applied pure ethanol (placebo)
|
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
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).
|
0-6 months
|
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.
|
0-6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammed Abu El-Hamd, MD, Faculty of Medicine, Sohag University, Egypt.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5/2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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