Back to resultsComparison 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)
Primary Purpose
Female Pattern Hair Loss
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Topical minoxidil 5% in pure ethanol alone
Placebo (Ethanol)
Sponsored by
About this trial
This is an interventional treatment trial for Female Pattern Hair Loss focused on measuring Female pattern hair loss, Minoxidil.
Eligibility Criteria
Inclusion Criteria:
- FPHL
Exclusion Criteria:
- No
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Topical minoxidil 5% in pure ethanol alone
Placebo
Arm Description
Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Group B applied topical minoxidil 5% in pure ethanol alone
Group C applied pure ethanol (placebo)
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04090801
Brief Title
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
Acronym
FPHL
Official Title
Minoxidil in Treatment of Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2015 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
January 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Hair Loss
Keywords
Female pattern hair loss, Minoxidil.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Arm Type
Active Comparator
Arm Description
Group A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Arm Title
Topical minoxidil 5% in pure ethanol alone
Arm Type
Active Comparator
Arm Description
Group B applied topical minoxidil 5% in pure ethanol alone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group C applied pure ethanol (placebo)
Intervention Type
Drug
Intervention Name(s)
Topical minoxidil 5% in 90% ethanol and 5% propylene glycol
Other Intervention Name(s)
Topical minoxidil 5% with 90% ethanol and 5% propylene glycol
Intervention Type
Drug
Intervention Name(s)
Topical minoxidil 5% in pure ethanol alone
Other Intervention Name(s)
Topical minoxidil 5%
Intervention Description
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
Intervention Type
Other
Intervention Name(s)
Placebo (Ethanol)
Intervention Description
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
Primary Outcome Measure Information:
Title
Ludwig scale grading system
Description
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).
Time Frame
0-6 months
Title
Trichoscopic examination of the hairs at frontal and occipital regions of the scalp.
Description
It will be evaluated signs of hair changes such as hair diameter diversity.
Time Frame
0-6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
FPHL
Exclusion Criteria:
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Abu El-Hamd, MD
Organizational Affiliation
Faculty of Medicine, Sohag University, Egypt.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs