Chest Hair EnhancementPhase 4NCT02283645
Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement
A Phase 4 study testing 3 % minoxidil lotion in people with Chest Hair Enhancement, run by Mae Fah Luang University Hospital.
Trial summary
The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for chest hair enhancement. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chest Hair Enhancement
- What is being tested?
- 3 % minoxidil lotion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male
Who cannot join
- serious underlying diseases
- history of chest/ hair treatment before 6 months
- history of surgery or trauma on chest area.
- history of minoxidil allergy
Trial locations and contacts
No sites are listed yet.
Chuchai Tanglertsampan, MD contact
Sittichai Ingprasert, MD contact
About this study
Official title: Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement : A Randomized, Double-blind, Placebo-controlled Study
The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for chest hair enhancement.
- Conditions
- Chest Hair Enhancement
- Being tested
- 3 % minoxidil lotion, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 % minoxidil lotionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Minoxidil | Experimental | 3% Minoxidil lotion is applied twice daily to the chest. Receives: Drug: 3 % minoxidil lotion |
| Placebo | Placebo comparator | Placebo lotion is applied twice daily to the chest. 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 20 weeks from baseline
Measured: baseline and 20 weeks
Secondary outcomes (1)
The change in number of hairs after 20 weeks from baseline
Measured: baseline and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest Hair EnhancementStudies 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
- 64 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02283645
- Sponsor's protocol ID
- REH-57080
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee S, Tanglertsampan C, Tanchotikul M, Worapunpong N. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study. J Dermatol. 2014 Feb;41(2):149-52. doi: 10.1111/1346-8138.12275. Epub 2013 Nov 8.
PubMed 24471459Suwanchatchai 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 22594928Tanglertsampan C. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study. J Med Assoc Thai. 2012 Oct;95(10):1312-6.
PubMed 23193746
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement : A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02283645
- Acronym / sponsor ID
- REH-57080
- Conditions
- Chest Hair Enhancement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mae Fah Luang University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 5 Nov 2014 (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 determine efficacy and safety of 3% minoxidil lotion for chest hair enhancement.
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 lotion3% Minoxidil lotion is applied twice daily to the chest. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo lotion is applied twice daily to the chest. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy male
Key exclusion criteria (4 listed)
- serious underlying diseases
- history of chest/ hair treatment before 6 months
- history of surgery or trauma on chest area.
- history of minoxidil allergy
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 lotion | Drug | Minoxidil |
| Placebo | Drug | Placebo |
Primary outcome
The change of global photographic assessment after 20 weeks from baseline
Time frame: baseline and 20 weeks
1 secondary outcome
The change in number of hairs after 20 weeks from baseline
Time frame: baseline and 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Results publication: PubMed 24471459Lee S, Tanglertsampan C, Tanchotikul M, Worapunpong N. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study. J Dermatol. 2014 Feb;41(2):149-52. doi: 10.1111/1346-8138.12275. Epub 2013 Nov 8.
- 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.
- Results publication: PubMed 23193746Tanglertsampan C. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study. J Med Assoc Thai. 2012 Oct;95(10):1312-6.
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 contact
Sittichai Ingprasert, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3 % minoxidil lotion in people with Chest Hair Enhancement, run by Mae Fah Luang University Hospital.
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 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chuchai Tanglertsampan, MD (drchuchait@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of global photographic assessment after 20 weeks from baseline (time frame: baseline and 20 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 NCT02283645, which also lists 3 linked publications.
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 2 Dec 2014.