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

• ClinicalTrials.gov Identifier: NCT01650272
• Recruitment Status: Unknown
• First Posted: July 26, 2012
• Last Update Posted: July 26, 2012
• Sponsor: Siriraj Hospital
• Information provided by (Responsible Party): Rattapon Thuangtong, Siriraj Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Objective (Goal); Self-Assessment; Adverse Effects	Drug: 5% MInoxidil milky lotion; Drug: 5% Minoxidil solution	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: An Efficacy and Safety Pilot Study Comparing 5% Monoxidil Milky Lotion Versus 5% Minoxidil Solution in Treatment of AGA
• Study Start Date: June 2012
• Estimated Primary Completion Date: February 2013
• Estimated Study Completion Date: April 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Efficacy of 5%Minoxidil milky lotion compare to 5%Minoxidil solution [ Time Frame: 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 :

1. Side effect of topical minoxidil [ Time Frame: 6 month ]
   Record side effect such as Erythema, Dryness, Pruritus, Scaling, etc.

Other Outcome Measures:

1. Weight of topical minoxidil milky lotion / minoxidil lotion [ Time Frame: 6 month ]
   Measure weight of topical minoxidil milky lotion / minoxidil lotion to confirm using of patient

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Rattapon Thuangtong, MD; +662 4194333; rattaponthuangtong@yahoo.com

Contact: Kanchalit Thanomkitti, MD, PhD; +668 95290298; kanchalitt@hotmail.com

Locations

Thailand

Siriraj Hospital; Recruiting

Bangkok, Thailand, 10700

Contact: Kanchalit Thanomkitti, MD +668 9529 0298 kanchalitt@hotmail.com

Principal Investigator: Rattapon Thuangtong,, MD

Sponsors and Collaborators

Siriraj Hospital

Investigators

• Principal Investigator: Rattapon Thuangtong, MD; Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

More Information

• Responsible Party: Rattapon Thuangtong, Assistant Professor, Siriraj Hospital
• ClinicalTrials.gov Identifier: NCT01650272
• Other Study ID Numbers: SirirajH-006
• First Posted: July 26, 2012
• Last Update Posted: July 26, 2012
• Last Verified: July 2012

Additional relevant MeSH terms:

Minoxidil; Pharmaceutical Solutions; Antihypertensive Agents; Vasodilator Agents