Minoxidil 1% for Eyebrow Enhancement

Eyebrow Hypotrichosis Clinical Trial

Official title:

Minoxidil 1% for Eyebrow Enhancement: A Randomized , Double-blind , Placebo-controlled , Split-face Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924000
• Other study ID #: REH-56059
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2013
• Last updated: April 20, 2014
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• 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 efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• male or female aged 18-60 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.

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

• Eyebrow Hypotrichosis
• Hypotrichosis
• Thin Eyebrow

Intervention

Drug:
• Minoxidil lotion 1%
Minoxidil lotion 1% is applied twice daily to one eyebrow.
• Placebo

Locations

Country	Name	City	State
Thailand	Mae Fah Luang University Hospital (Bangkok)	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mae Fah Luang University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Suwanchatchai W, Tanglertsampan C, Pengsalae N, Makornwattana M. Efficacy and safety of bimatoprost 0.03% versus minoxidil 3% in enhancement of eyebrows: a randomized, double-blind, split-face comparative study. J Dermatol. 2012 Oct;39(10):865-6. doi: 10. — View Citation

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		baseline and 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