Efficacy and Safety of 3% Minoxidil Lotion for Chest Hair Enhancement

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

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

Study Overview

• Status: Unknown
• Conditions: Chest Hair Enhancement
• Intervention / Treatment: Drug: Placebo; Drug: 3 % minoxidil lotion

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Chuchai Tanglertsampan, MD; Email: drchuchait@yahoo.com
• Study Contact Backup: Name: Sittichai Ingprasert, MD; Email: sittichai113@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• healthy male

Exclusion Criteria:

• serious underlying diseases
• history of chest/ hair treatment before 6 months
• history of surgery or trauma on chest 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 chest.	Drug: 3 % minoxidil lotion
Placebo Comparator: Placebo; Placebo lotion is applied twice daily to the chest.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of global photographic assessment after 20 weeks from baseline	baseline and 20 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in number of hairs after 20 weeks from baseline	baseline and 20 weeks

Other Outcome Measures

Outcome Measure	Time Frame
The change of hair diameter after 20 weeks from baseline	baseline and 20 weeks
Number of participants with adverse events	baseline and 20 weeks
Patient satisfaction by self-assessment questionnaires	baseline and 20 weeks

Collaborators and Investigators

• Sponsor: Mae Fah Luang University Hospital

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: January 1, 2015
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: November 2, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 29, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: REH-57080