Female Pattern Hair LossPhase 4FPHLNCT04090801
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
A Phase 4 study testing Topical minoxidil 5% in 90% ethanol and 5% propylene glycol and Topical minoxidil 5% in pure ethanol alone in people with Female Pattern Hair Loss, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Pattern Hair Loss
- What is being tested?
- Topical minoxidil 5% in 90% ethanol and 5% propylene glycol and Topical minoxidil 5% in pure ethanol alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2015to 23 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- FPHL
Who cannot join
- No
About this study
Official title: Minoxidil in Treatment of Androgenetic Alopecia
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.
Read the 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
- Being tested
- Topical minoxidil 5% in 90% ethanol and 5% propylene glycol, Topical minoxidil 5% in pure ethanol alone, Placebo (Ethanol)
- Keywords
- Female pattern hair loss, Minoxidil.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical minoxidil 5% in 90% ethanol and 5% propylene glycolDrug
Also called Topical minoxidil 5% with 90% ethanol and 5% propylene glycol
Topical minoxidil 5% in pure ethanol aloneDrug
Also called Topical minoxidil 5%
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
Placebo (Ethanol)Other
The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Topical minoxidil 5% in pure ethanol alone |
| Placebo | Placebo comparator | Group C applied pure ethanol (placebo) Receives: Other: Placebo (Ethanol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start30 May 2015
- Primary completion30 May 2016
- Study completion23 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern Hair LossStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abu El-Hamd, Sohag University
- Investigators
- Mohammed Abu El-Hamd, MD, Principal investigator, Faculty of Medicine, Sohag University, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090801
- Sponsor's protocol ID
- 5/2015
- Acronym
- FPHL
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minoxidil in Treatment of Androgenetic Alopecia
- ClinicalTrials.gov ID
- NCT04090801
- Acronym / sponsor ID
- FPHL / 5/2015
- Conditions
- Female Pattern Hair Loss
- Keywords
- Female pattern hair loss, Minoxidil.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 May 2015 (actual)
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 23 Jan 2017 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Topical minoxidil 5% in 90% ethanol and 5% propylene glycol | Active comparator | Drug: Topical minoxidil 5% in 90% ethanol and 5% propylene glycolGroup A applied topical minoxidil 5% in 90% ethanol and 5% propylene glycol |
| Topical minoxidil 5% in pure ethanol alone | Active comparator | Drug: Topical minoxidil 5% in pure ethanol aloneGroup B applied topical minoxidil 5% in pure ethanol alone |
| Placebo | Placebo comparator | Other: Placebo (Ethanol)Group C applied pure ethanol (placebo) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- FPHL
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical minoxidil 5% in 90% ethanol and 5% propylene glycolAlso: Topical minoxidil 5% with 90% ethanol and 5% propylene glycol | Drug | Topical minoxidil 5% in 90% ethanol and 5% propylene glycol |
| Topical minoxidil 5% in pure ethanol aloneAlso: Topical minoxidil 5%The treatment will be continued twice daily.for six months with regular visits at 3 months intervals. | Drug | Topical minoxidil 5% in pure ethanol alone |
| Placebo (Ethanol)The treatment will be continued twice daily.for six months with regular visits at 3 months intervals. | Other | Placebo |
Primary outcome
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Abu El-Hamd, MD principal investigator
Faculty of Medicine, Sohag University, Egypt.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical minoxidil 5% in 90% ethanol and 5% propylene glycol and Topical minoxidil 5% in pure ethanol alone in people with Female Pattern Hair Loss, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ludwig scale grading system (time frame: 0-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.