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

Study Overview
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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.

Official Title
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An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA

Conditions
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Objective (Goal), Self-Assessment, Adverse Effects

Intervention / Treatment
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* Drug: 5% MInoxidil milky lotion
* Drug: 5% Minoxidil solution


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5%Minoxidil solution<br>This arm AGA patient receive 5%Minoxidil solution ( Propylene glycol solvent ) to use for 6 month. Record efficacy and safety as described. | Drug: 5% Minoxidil solution<br>* Patient receive 5% Minoxidil solution (Propylene glycol solvent )<br>* Other names: Minoxidil lotion;|
| Experimental: 5%Minoxidil milky lotion<br>This arm AGA patient receive 5%Minoxidil milky lotion to use for 6 month. Record efficacy and safety as described. | Drug: 5% MInoxidil milky lotion<br>* Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)<br>* Other names: MInoxidil milk lotion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution | Target area hair evaluation Hair density (Digital image, DinoLite pro) Hair diameter (Electronic outside micrometer) Hair count vellus/ non-vellus ratio Global photographic review (by 2 Experienced Dermatologist) Patient self evaluation ( 7point scale ) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect of topical minoxidil | Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc. | 6 month |