Minoxidil 1% for Eyebrow Enhancement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier:
NCT01924000
First received: August 13, 2013
Last updated: April 20, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Eyebrow Hypotrichosis
Thin Eyebrow
Drug: Minoxidil lotion 1%
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

Resource links provided by NLM:


Further study details as provided by Mae Fah Luang University Hospital:

Primary Outcome Measures:
  • The change of global photographic assessment after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of hair diameter after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The change in number of hairs after 16 weeks from baseline [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events. Adverse events include any skin rashes or symptoms. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Patient satisfaction by self-assessment questionnaires [ Time Frame: baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

Additional Information:
Publications:
Responsible Party: Chuchai TANGLERTSAMPAN, MD, Instructor, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT01924000     History of Changes
Other Study ID Numbers: REH-56059
Study First Received: August 13, 2013
Last Updated: April 20, 2014
Health Authority: Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Minoxidil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014