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Minoxidil 2% for Eyebrow Enhancement

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ClinicalTrials.gov Identifier: NCT01672307
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.

Condition or disease Intervention/treatment Phase
Hypotrichosis of Eyebrows Thinning Eyebrows Drug: Minoxidil lotion 2% Drug: Placebo Phase 4

Study Design
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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: Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study
Study Start Date : September 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Minoxidil
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Minoxidil lotion 2%
Minoxidil lotion 2% is applied twice daily to one eyebrow.
 Drug: Minoxidil lotion 2%
Minoxidil lotion 2% is applied twice daily to one eyebrow.
Placebo Comparator: Placebo
Placebo is applied twice daily to the other eyebrow.
 Drug: Placebo
Placebo is applied twice daily to the other eyebrow.


Outcome Measures
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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: 16 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female aged 18-40 years
  • hypotrichosis of eyebrows
  • healthy
  • informed consent obtained

Exclusion Criteria:

  • no underlying diseases
  • no alopecia areata or trichotillomania
  • no thyroid diseases
  • no pregnancy or breast feeding
  • no previous eyebrow tattoo, trauma or accident.
  • no history of eyebrow or hair medications in 6 months
  • no history of minoxidil or its ingredient allergy
  • no history of eyebrow surgery.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01672307


Locations
Thailand
MFL University Hospital (Bangkok)
Bangkok, Thailand, 10110
Sponsors and Collaborators
Mae Fah Luang University Hospital
Investigators
Principal Investigator: Chuchai Tanglertsampan, MD MFL University Hospital (Bangkok)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Chuchai TANGLERTSAMPAN, MD, Instructor, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT01672307     History of Changes
Other Study ID Numbers: MFL University
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital:
hypotrichosis of eyebrows
thinning eyebrows
minoxidil
placebo
randomized

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