NCT01672307

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

August 19, 2012

Last Update Submit

June 18, 2013

Conditions

Hypotrichosis of EyebrowsThinning Eyebrows

Keywords

hypotrichosis of eyebrowsthinning eyebrowsminoxidilplaceborandomized

Outcome Measures

Primary Outcomes (1)

  • The change of global photographic assessment after 16 weeks from baseline

    baseline and 16 weeks

Secondary Outcomes (1)

  • The change of hair diameter after 16 weeks from baseline

    baseline and 16 weeks

Other Outcomes (3)

  • The change in number of hairs after 16 weeks from baseline

    baseline and 16 weeks

  • Number of participants with adverse events. Adverse events include any skin rashes or symptoms.

    16 weeks

  • Patient satisfaction by self-assessment questionnaires

    16 weeks

Study Arms (2)

Minoxidil lotion 2%

EXPERIMENTAL

Minoxidil lotion 2% is applied twice daily to one eyebrow.

Drug: Minoxidil lotion 2%

Placebo

PLACEBO COMPARATOR

Placebo is applied twice daily to the other eyebrow.

Drug: Placebo

Interventions

Minoxidil lotion 2%DRUG

Minoxidil lotion 2% is applied twice daily to one eyebrow.

Minoxidil lotion 2%
PlaceboDRUG

Placebo is applied twice daily to the other eyebrow.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MFL University Hospital (Bangkok)

Bangkok, 10110, Thailand

Location

Study Officials

  • Chuchai Tanglertsampan, MD

    MFL University Hospital (Bangkok)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

August 19, 2012

First Posted

August 24, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

March 1, 2013

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

TH(1)