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Trial record 2 of 33 for:    Open Studies | "Hypotrichosis"
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Minoxidil 2% for Enhancement of Eyebrows

This study is not yet open for participant recruitment.
Verified August 2012 by Mae Fah Luang University Hospital
Sponsor:
Information provided by (Responsible Party):
Chuchai TANGLERTSAMPAN, MD, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier:
NCT01672307
First received: August 19, 2012
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of the study is to compare minoxidil 2% versus placebo in enhancement of eyebrows.


Condition Intervention Phase
Hypotrichosis of Eyebrows
Thinning Eyebrows
 Drug: Minoxidil lotion 2%
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: Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

Resource links provided by NLM:

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

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: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672307

Contacts
Contact: Chuchai Tanglertsampan, MD 02-664-2295 drchuchait@yahoo.com
Contact: Saridpong Sae-Lee, MD 084-466-7339 saridponglee@gmail.com

Locations
Thailand
MFL University Hospital (Bangkok) Not yet recruiting
Bangkok, Thailand, 10110
Contact: Chuchai Tanglertsampan, MD     02-664-2295     drchuchait@yahoo.com    
Contact: Saridpong Sae-Lee, MD     084-466-7339     saridponglee@gmail.com    
Principal Investigator: Chuchai Tanglertsampan, MD            
Sub-Investigator: Saridpong Sae-Lee, MD            
Sponsors and Collaborators
Mae Fah Luang University Hospital
Investigators
Principal Investigator: Chuchai Tanglertsampan, MD MFL University Hospital (Bangkok)
  More Information

No publications provided

Responsible Party: Chuchai TANGLERTSAMPAN, MD, Instructor, Mae Fah Luang University Hospital
ClinicalTrials.gov Identifier: NCT01672307     History of Changes
Other Study ID Numbers: MFL University
Study First Received: August 19, 2012
Last Updated: August 23, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by 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
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013