NCT01391156

Brief Summary

The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 1, 2011

Last Update Submit

July 19, 2012

Conditions

Androgenetic Alopecia

Keywords

minoxidilfinasteridetopicallotionmale pattern hair lossandrogenetic alopecia

Outcome Measures

Primary Outcomes (1)

  • The mean change of hair count from baseline and 6 months

    Total hair count on the vertex is measured on 1 cm2 circular area. The mean change in hair count is compared at baseline and 6 months.The significance of change is determined by Unpaired t Test.

    baseline and 6 months

Secondary Outcomes (1)

  • Global photographic assessment by dermatologists

    baseline and 6 months

Study Arms (2)

Minoxidil

EXPERIMENTAL
Drug: 3%Minoxidil lotion

MinoxidilFinasteride

ACTIVE COMPARATOR
Drug: 3% Minoxidil with 0.1% Finasteride lotion

Interventions

3%Minoxidil lotionDRUG

3% Minoxidil lotion apply two times a day

Minoxidil
3% Minoxidil with 0.1% Finasteride lotionDRUG

3% Minoxidil with 0.1% Finasteride lotion apply two times a day.

MinoxidilFinasteride

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male, age 18-15 years
  • androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)

You may not qualify if:

  • use minoxidil in 6 months
  • use finasteride in 12 months
  • use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks
  • seborrheic dermatitis or psoriasis on scalp
  • history of allergy to minoxidil, finasteride

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mae Fah Luang University Hospital(Bangkok)

Bangkok, Bangkok, Thailand

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Chuchai Tanglertsampan, MD

    Mae Fah Luang University Hospital(Bangkok)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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
Chuchai Tanglertsampan, MD

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 11, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations

TH(1)