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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adverse Effects; Self-Assessment; Objective (Goal)
• Intervention / Treatment: Drug: 5% Minoxidil solution; Drug: 5% MInoxidil milky lotion

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rattapon Thuangtong, MD; Phone Number: +662 4194333; Email: rattaponthuangtong@yahoo.com
• Study Contact Backup: Name: Kanchalit Thanomkitti, MD, PhD; Phone Number: +668 95290298; Email: kanchalitt@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
    • Contact: Kanchalit Thanomkitti, MD; Phone Number: +668 9529 0298; Email: kanchalitt@hotmail.com
    • Principal Investigator: Rattapon Thuangtong,, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 5% Minoxidil solution; Patient receive 5% Minoxidil solution (Propylene glycol solvent ); Other Names: Minoxidil solution; Minoxidil lotion
Experimental: 5%Minoxidil milky lotion; 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; Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent); Other Names: MInoxidil milky lotion; MInoxidil milk lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution	Target area hair evaluationHair 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight of topical minoxidil milky lotion / minoxidil lotion	Measure weight of topical minoxidil milky lotion / minoxidil lotion to confirm using of patient	6 month

Collaborators and Investigators

• Sponsor: Siriraj Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: July 23, 2012
• First Submitted That Met QC Criteria: July 25, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): July 26, 2012
• Last Update Submitted That Met QC Criteria: July 25, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Vasodilator Agents; Pharmaceutical Solutions; Minoxidil
• Other Study ID Numbers: SirirajH-006