Androgenetic AlopeciaPhase 3NCT01391156
Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss
A Phase 3 study testing 3%Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion in people with Androgenetic Alopecia, run by Mae Fah Luang University Hospital at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- 3%Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2011to Mar 2012
- Phase
- Phase 3
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male, age 18-15 years
- androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)
Who cannot join
- use minoxidil in 6 months
- use finasteride in 12 months
- use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks
- seborrheic dermatitis or psoriasis on scalp
- history of allergy to minoxidil, finasteride
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of 3% Minoxidil Versus Combined 3% Minoxidil and 0.1% Finasteride for Male Pattern Hair Loss: a Randomized, Double-blinded, Comparative Study
The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.
- Conditions
- Androgenetic Alopecia
- Being tested
- 3%Minoxidil lotion, 3% Minoxidil with 0.1% Finasteride lotion
- Keywords
- minoxidil, finasteride, topical, lotion, male pattern hair loss, androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3%Minoxidil lotionDrug
3% Minoxidil lotion apply two times a day
3% Minoxidil with 0.1% Finasteride lotionDrug
3% Minoxidil with 0.1% Finasteride lotion apply two times a day.
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil | Experimental | Not described Receives: Drug: 3%Minoxidil lotion |
| MinoxidilFinasteride | Active comparator | Not described Receives: Drug: 3% Minoxidil with 0.1% Finasteride lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change of hair count from baseline and 6 months
Total hair count on the vertex is measured on 1 cm2 circular area. The mean change in hair count is compared at baseline and 6 months.The significance of change is determined by Unpaired t Test.
Measured: baseline and 6 months
Secondary outcomes (1)
Global photographic assessment by dermatologists
Photographs of the vertex scalp are taken at baseline and 6 months. A panel of 3 dermatologists assesssed the change in hair growth using a 7-point scale.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mae Fah Luang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
- Investigators
- Chuchai Tanglertsampan, MD, Principal investigator, Mae Fah Luang University Hospital(Bangkok)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391156
- Sponsor's protocol ID
- REH-54015
- Status last verified
- Jul 2012
- First submitted
- 1 Jul 2011
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3% Minoxidil Versus Combined 3% Minoxidil and 0.1% Finasteride for Male Pattern Hair Loss: a Randomized, Double-blinded, Comparative Study
- ClinicalTrials.gov ID
- NCT01391156
- Acronym / sponsor ID
- REH-54015
- Conditions
- Androgenetic Alopecia
- Keywords
- minoxidil, finasteride, topical, lotion, male pattern hair loss, androgenetic alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mae Fah Luang University HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Jul 2011 (estimated)
- 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 purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minoxidil | Experimental | Drug: 3%Minoxidil lotion |
| MinoxidilFinasteride | Active comparator | Drug: 3% Minoxidil with 0.1% Finasteride lotion |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male, age 18-15 years
- androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)
Key exclusion criteria (5 listed)
- use minoxidil in 6 months
- use finasteride in 12 months
- use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks
- seborrheic dermatitis or psoriasis on scalp
- history of allergy to minoxidil, finasteride
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 |
|---|---|---|
| 3%Minoxidil lotion3% Minoxidil lotion apply two times a day | Drug | Minoxidil |
| 3% Minoxidil with 0.1% Finasteride lotion3% Minoxidil with 0.1% Finasteride lotion apply two times a day. | Drug | MinoxidilFinasteride |
Primary outcome
The mean change of hair count from baseline and 6 months
Time frame: baseline and 6 months
Total hair count on the vertex is measured on 1 cm2 circular area. The mean change in hair count is compared at baseline and 6 months.The significance of change is determined by Unpaired t Test.
1 secondary outcome
Global photographic assessment by dermatologists
Time frame: baseline and 6 months
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 20 Jul 2012.
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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.
Chuchai Tanglertsampan, MD principal investigator
Mae Fah Luang University Hospital(Bangkok)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3%Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion in people with Androgenetic Alopecia, run by Mae Fah Luang University Hospital at 1 site in Thailand.
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 2 inclusion and 5 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 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The mean change of hair count from baseline and 6 months (time frame: baseline and 6 months). 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 20 Jul 2012.