Minoxidil 2% for Eyebrow Enhancement

Hypotrichosis of Eyebrows Clinical Trial

Official title:

Efficacy and Tolerability of Minoxidil 2% for Eyebrow Enhancement : A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01672307
• Other study ID #: MFL University
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2012
• Last updated: June 18, 2013
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Mae Fah Luang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotrichosis
• Hypotrichosis of Eyebrows
• Thinning Eyebrows

Intervention

Drug:
• Minoxidil lotion 2%
Minoxidil lotion 2% is applied twice daily to one eyebrow.
• Placebo
Placebo is applied twice daily to the other eyebrow.

Locations

Country	Name	City	State
Thailand	MFL University Hospital (Bangkok)	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mae Fah Luang University Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change in number of hairs after 16 weeks from baseline		baseline and 16 weeks	No
Other	Number of participants with adverse events. Adverse events include any skin rashes or symptoms.		16 weeks	Yes
Other	Patient satisfaction by self-assessment questionnaires		16 weeks	No
Primary	The change of global photographic assessment after 16 weeks from baseline		baseline and 16 weeks	No
Secondary	The change of hair diameter after 16 weeks from baseline		baseline and 16 weeks	No