Minoxidil 2% 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:

NCT01672307

First received: August 19, 2012

Last updated: June 18, 2013

Last verified: June 2013

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 ]


Enrollment:	40
Study Start Date:	September 2012
Study Completion Date:	March 2013
Primary Completion Date:	November 2012 (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

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: 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

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:	June 18, 2013
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 Pharmacologic Actions Therapeutic Uses Vasodilator Agents

ClinicalTrials.gov processed this record on March 03, 2015

To Top