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

Information source: Siriraj Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Objective (Goal); Self-Assessment; Adverse Effects

Intervention: 5% MInoxidil milky lotion (Drug); 5% Minoxidil solution (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Siriraj Hospital

Official(s) and/or principal investigator(s):
Rattapon Thuangtong, MD, Principal Investigator, Affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Overall contact:
Rattapon Thuangtong, MD, Phone: +662 4194333, Email: rattaponthuangtong@yahoo.com

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.

Clinical Details

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

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

Primary outcome: Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution

Secondary outcome: Side effect of topical minoxidil

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

Locations and Contacts

Rattapon Thuangtong, MD, Phone: +662 4194333, Email: rattaponthuangtong@yahoo.com

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

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

Starting date: June 2012
Last updated: July 25, 2012

Page last updated: August 23, 2015

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