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

Phase 1

• Conditions: Objective (Goal); Self-Assessment; Adverse Effects
• Interventions: Drug: 5% Minoxidil solution; Drug: 5% MInoxidil milky lotion

• Registration Number: NCT01650272
• Lead Sponsor: Siriraj Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-06
• Status Verified: 2012-07
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-25
• Last Update Submitted: 2012-07-25
• Study First Posted: 2012-07-26
• Last Update Posted: 2012-07-26
• Primary Completion: 2013-02
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution	6 month	1. Target area hair evaluation; * Hair density (Digital image, DinoLite pro); * Hair diameter (Electronic outside micrometer); * Hair count vellus/ non-vellus ratio; 2. Global photographic review (by 2 Experienced Dermatologist); 3. Patient self evaluation ( 7point scale )

Secondary Outcome Measures

Name	Time	Method
Side effect of topical minoxidil	6 month	Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc.

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand