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

Adverse Effects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650272
• Other study ID #: SirirajH-006
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 23, 2012
• Last updated: July 25, 2012
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2012
• Source: Siriraj Hospital
• Contact: Rattapon Thuangtong, MD
• Phone: +662 4194333
• Email: rattaponthuangtong[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effects
• Objective (Goal)
• Self-Assessment

Intervention

Drug:
• 5% MInoxidil milky lotion
Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)
• 5% Minoxidil solution
Patient receive 5% Minoxidil solution (Propylene glycol solvent )

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight of topical minoxidil milky lotion / minoxidil lotion	Measure weight of topical minoxidil milky lotion / minoxidil lotion to confirm using of patient	6 month	No
Primary	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	No
Secondary	Side effect of topical minoxidil	Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc.	6 month	Yes

External Links

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