Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement

Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study

The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.

Study Overview

• Status: Completed
• Conditions: Beard Enhancement
• Intervention / Treatment: Drug: Placebo; Drug: 3 % Minoxidil lotion

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • MFL University Hospital (Bangkok)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male

Exclusion Criteria:

• serious underlying diseases.
• history of beard/ hair treatment before 6 months
• history of surgery or trauma on beard area.
• history of minoxidil allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minoxidil; 3% Minoxidil lotion is applied twice daily to the beard.	Drug: 3 % Minoxidil lotion
Placebo Comparator: Placebo; Placebo is applied twice daily to beard.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of global photographic assessment after 16 weeks from baseline	baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in number of hairs after 16 weeks from baseline	baseline and 16 weeks

Other Outcome Measures

Outcome Measure	Time Frame
The change of hair diameter after 16 weeks from baseline	baseline and 16 weeks
Patient satisfaction by self-assessment questionnaires	baseline and 16 weeks
Number of participants with adverse events	baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Mae Fah Luang University Hospital
• Investigators: Principal Investigator: Chuchai Tanglertsampan, MD, MFL University Hospital (Bangkok)

Publications and helpful links

General Publications

• Lee S, Tanglertsampan C, Tanchotikul M, Worapunpong N. Minoxidil 2% lotion for eyebrow enhancement: a randomized, double-blind, placebo-controlled, spilt-face comparative study. J Dermatol. 2014 Feb;41(2):149-52. doi: 10.1111/1346-8138.12275. Epub 2013 Nov 8.
• 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: 10.1111/j.1346-8138.2012.01579.x. Epub 2012 May 17. No abstract available.
• Tanglertsampan C. Efficacy and safety of 3% minoxidil versus combined 3% minoxidil / 0.1% finasteride in male pattern hair loss: a randomized, double-blind, comparative study. J Med Assoc Thai. 2012 Oct;95(10):1312-6.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 27, 2014

Study Record Updates

• Last Update Posted (Estimate): April 22, 2015
• Last Update Submitted That Met QC Criteria: April 21, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: REH-57077