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Efficacy and Safety Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Androgenetic Alopecia

NCT ID: NCT01650272

Last Updated: 2012-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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5% Minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by US FDA science 1988. The mechanism of action still unclear. In general the 5% Minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (Ebner H. et al,1995). Propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (Friedman ES. et al. 2002) One of the alternative solution using butylene glycol as the solvent was invented to solve the problem. In Siriraj hospital the investigators using this new solvent and made our in house product called 5% Minoxidil milky lotion. However the efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

Detailed Description

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The 5% Minoxidil in solution is the first choice preparation for treatment for Androgenetic Alopecia (AGA), 5% Minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. In Siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. This study is conducted to evaluated efficacy and safety of 5% Minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

Conditions

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Objective (Goal) Self-Assessment Adverse Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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5%Minoxidil solution

This arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month.

Record efficacy and safety as described.

Group Type EXPERIMENTAL

5% Minoxidil solution

Intervention Type DRUG

Patient receive 5% Minoxidil solution (Propylene glycol solvent )

5%Minoxidil milky lotion

This arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described.

Group Type EXPERIMENTAL

5% MInoxidil milky lotion

Intervention Type DRUG

Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)

Interventions

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5% MInoxidil milky lotion

Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)

Intervention Type DRUG

5% Minoxidil solution

Patient receive 5% Minoxidil solution (Propylene glycol solvent )

Intervention Type DRUG

Other Intervention Names

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MInoxidil milky lotion MInoxidil milk lotion Minoxidil solution Minoxidil lotion

Eligibility Criteria

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Inclusion Criteria

* New case male AGA
* Classification Norwood III vertex or IV

Exclusion Criteria

* Have previous AGA treatment in 6 month prior
* Complicated case with other disease condition effect hair such as Anemia, DM, Chronic alcoholism, Autoimmune disease, Thyroid disease, previous GI surgery etc.
* Other scalp lesion such as Psoriasis, Tinea capsitis
* Psychological disorder including trichotillomania
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rattapon Thuangtong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rattapon Thuangtong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

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Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Rattapon Thuangtong, MD

Role: CONTACT

Phone: +662 4194333

Email: [email protected]

Kanchalit Thanomkitti, MD, PhD

Role: CONTACT

Phone: +668 95290298

Email: [email protected]

Facility Contacts

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Kanchalit Thanomkitti, MD

Role: primary

Other Identifiers

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SirirajH-006

Identifier Type: -

Identifier Source: org_study_id