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Minoxidil 1% for Eyebrow Enhancement

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ClinicalTrials.gov Identifier: NCT01924000
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : April 22, 2014
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital

Brief Summary:
The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.

Condition or disease Intervention/treatment Phase
Eyebrow Hypotrichosis Thin Eyebrow Drug: Minoxidil lotion 1% Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
Study Start Date : December 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Minoxidil lotion 1%
Minoxidil lotion 1% is applied twice daily to one eyebrow.
Drug: Minoxidil lotion 1%
Minoxidil lotion 1% is applied twice daily to one eyebrow.
Placebo Comparator: Placebo
Placebo is applied twice daily to the other eyebrow.
Drug: Placebo
Other Name: Placebo is applied twice daily on the other eyebrow.



Primary Outcome Measures :
  1. The change of global photographic assessment after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]

Secondary Outcome Measures :
  1. The change of hair diameter after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]

Other Outcome Measures:
  1. The change in number of hairs after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ]
  2. Number of participants with adverse events. Adverse events include any skin rashes or symptoms. [ Time Frame: 16 weeks ]
  3. Patient satisfaction by self-assessment questionnaires [ Time Frame: baseline and 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female aged 18-60 years
  • hypotrichosis of eyebrows
  • healthy
  • informed consent obtained

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924000


Locations
Thailand
Mae Fah Luang University Hospital (Bangkok)
Bangkok, Thailand
Sponsors and Collaborators
Mae Fah Luang University Hospital
Investigators
Principal Investigator: Chuchai Tanglertsampan, MD Mae Fah Luang University Hospital (Bangkok)

Publications of Results:
Responsible Party: Chuchai TANGLERTSAMPAN, MD, Instructor, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT01924000     History of Changes
Other Study ID Numbers: REH-56059
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: April 22, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Minoxidil
Antihypertensive Agents
Vasodilator Agents