Eyebrow HypotrichosisPhase 4NCT01924000
Minoxidil 1% for Eyebrow Enhancement
A Phase 4 study testing Minoxidil lotion 1% in people with Eyebrow Hypotrichosis and Thin Eyebrow, run by Mae Fah Luang University Hospital at 1 site in Thailand.
Trial summary
The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eyebrow Hypotrichosis, Thin Eyebrow
- What is being tested?
- Minoxidil lotion 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2013to Apr 2014
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male or female aged 18-60 years
- hypotrichosis of eyebrows
- healthy
- informed consent obtained
Who cannot join
- underlying diseases
- alopecia areata or trichotillomania
- thyroid diseases
- pregnancy or breast feeding
- previous eyebrow tattoo, trauma or accident.
- history of eyebrow or hair medications in 6 months
- history of minoxidil or its ingredient allergy
- history of eyebrow surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.
- Conditions
- Eyebrow Hypotrichosis, Thin Eyebrow
- Being tested
- Minoxidil lotion 1%, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minoxidil lotion 1%Drug
Minoxidil lotion 1% is applied twice daily to one eyebrow.
PlaceboDrug
Also called Placebo is applied twice daily on the other eyebrow.
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil lotion 1% | Experimental | Minoxidil lotion 1% is applied twice daily to one eyebrow. Receives: Drug: Minoxidil lotion 1% |
| Placebo | Placebo comparator | Placebo is applied twice daily to the other eyebrow. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of global photographic assessment after 16 weeks from baseline
Measured: baseline and 16 weeks
Secondary outcomes (1)
The change of hair diameter after 16 weeks from baseline
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eyebrow HypotrichosisStudies 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 4
- 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
- NCT01924000
- Sponsor's protocol ID
- REH-56059
- Status last verified
- Apr 2014
- First submitted
- 13 Aug 2013
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.
PubMed 22594928
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
- ClinicalTrials.gov ID
- NCT01924000
- Acronym / sponsor ID
- REH-56059
- Conditions
- Eyebrow Hypotrichosis, Thin Eyebrow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mae Fah Luang University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Aug 2013 (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 the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.
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 lotion 1% | Experimental | Drug: Minoxidil lotion 1%Minoxidil lotion 1% is applied twice daily to one eyebrow. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is applied twice daily to the other eyebrow. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- male or female aged 18-60 years
- hypotrichosis of eyebrows
- healthy
- informed consent obtained
Key exclusion criteria (8 listed)
- underlying diseases
- alopecia areata or trichotillomania
- thyroid diseases
- pregnancy or breast feeding
- previous eyebrow tattoo, trauma or accident.
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 |
|---|---|---|
| Minoxidil lotion 1%Minoxidil lotion 1% is applied twice daily to one eyebrow. | Drug | Minoxidil lotion 1% |
| PlaceboAlso: Placebo is applied twice daily on the other eyebrow. | Drug | Placebo |
Primary outcome
The change of global photographic assessment after 16 weeks from baseline
Time frame: baseline and 16 weeks
1 secondary outcome
The change of hair diameter after 16 weeks from baseline
Time frame: baseline and 16 weeks
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 22 Apr 2014.
- Results publication: PubMed 22594928Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.
- Related InfoLink provided by the sponsor.
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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 4 study testing Minoxidil lotion 1% in people with Eyebrow Hypotrichosis and Thin Eyebrow, 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 4 inclusion and 8 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 22 Apr 2014. 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. 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?
The change of global photographic assessment after 16 weeks from baseline (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01924000, which also lists 1 linked publication.
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 22 Apr 2014.