NCT02283645

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_4

Status
unknown

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

November 2, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

7 months

First QC Date

November 2, 2014

Last Update Submit

November 29, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • The change of global photographic assessment after 20 weeks from baseline

    baseline and 20 weeks

Secondary Outcomes (1)

  • The change in number of hairs after 20 weeks from baseline

    baseline and 20 weeks

Other Outcomes (3)

  • 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

Study Arms (2)

Minoxidil

EXPERIMENTAL

3% Minoxidil lotion is applied twice daily to the chest.

Drug: 3 % minoxidil lotion

Placebo

PLACEBO COMPARATOR

Placebo lotion is applied twice daily to the chest.

Drug: Placebo

Interventions

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

Central Study Contacts

Chuchai Tanglertsampan, MD

CONTACT

Sittichai Ingprasert, MD

CONTACT

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
Assitant Professor

Study Record Dates

First Submitted

November 2, 2014

First Posted

November 5, 2014

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 2, 2014

Record last verified: 2014-11