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Minoxidil 1% for Eyebrow Enhancement

This study is currently recruiting participants.
Verified March 2014 by Mae Fah Luang University Hospital
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: March 5, 2014
Last verified: March 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 ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: April 2014
Estimated 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 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male or female aged 18-40 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924000

Contacts
Contact: Chuchai Tanglertsampan, MD 053-916-000 drchuchait@yahoo.com
Contact: Nigun Worapunpong, MD arachi21628@hotmail.com

Locations
Thailand
Mae Fah Luang University Hospital (Bangkok) Recruiting
Bangkok, Thailand
Contact: Chuchai Tanglertsampan, MD       drchuchait@yahoo.com   
Contact: Nigun Worapunpong, MD       arachi21628@hotmail.com   
Principal Investigator: Chuchai Tanglertsampan, MD         
Sub-Investigator: Nigun Worapunpong, MD         
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: March 5, 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 April 17, 2014