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

NCT01650272 | Unknown Phase 1 DMC

• 1 other identifier: SirirajH-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Objective (Goal); Self-Assessment; Adverse Effects

Outcome Measures

Primary Outcomes (1)

• Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution

  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 )

  6 month

Secondary Outcomes (1)

• Side effect of topical minoxidil

  6 month

Other Outcomes (1)

• Weight of topical minoxidil milky lotion / minoxidil lotion

  6 month

Study Arms (2)

5%Minoxidil solution

EXPERIMENTAL

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

5%Minoxidil milky lotion

EXPERIMENTAL

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

Interventions

5% MInoxidil milky lotion DRUG

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

Also known as: MInoxidil milky lotion, MInoxidil milk lotion

5%Minoxidil milky lotion

5% Minoxidil solution DRUG

Patient receive 5% Minoxidil solution (Propylene glycol solvent )

Also known as: Minoxidil solution, Minoxidil lotion

5%Minoxidil solution

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

RECRUITING

Study Officials

• Rattapon Thuangtong, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rattapon Thuangtong, MD

CONTACT

+662 4194333; rattaponthuangtong@yahoo.com

Kanchalit Thanomkitti, MD, PhD

CONTACT

+668 95290298; kanchalitt@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 26, 2012
• Study Start: June 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

TH (1)