The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Androgenetic Alopecia Clinical Trial

Official title:

The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548066
• Other study ID #: VPA_hair
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2011
• Last updated: October 5, 2012
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Beta-catenin, the transducer of Wnt signaling, is critical in development, growth, and regeneration of hair. In the absence of Wnt signals, cytoplasmic β-catenin is maintained at low level through regulation by GSK-3, multifunctional serine/threonin kinase. After phosphorylation by GSK-3, β-catenin is ubiquitinated and degraded in cytoplasm. Therefore, inhibition of GSK-3 is able to increase β-catenin in nucleus and would be able to induce growth of hair. Valproic acid (VPA) is an anticonvulsant and mood-stabilizing drug used for decades and is known to inhibit the GSK-3β. However, the effect of VPA on hairs has not been studied yet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

• age: 19 years ~ 45 years

• subjects with AGA (Hamilton&Norwood grad III~IV)

• subjects who are able to be followed for next 24 weeks.

Exclusion Criteria:

• subjects with severe medical problems including cardiovascular diseases, renal problems, and chronic metabolic disease

• subjects with AGA treated with surgical methods (hair TPL)

• subjects who has ever applied minoxidil in recent 3 months or has taken finasteride or dutasteride in recent 6 months.

• subjects who took medicine which can affect the hair growth

• subjects with alopecia other than AGA

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia
• Male Pattern Baldness

Intervention

Drug:
• Valproic Acid
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
• Control placebo
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Department of Dermatology, Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	linear hair growth rate	the average growth rate of hair shaft for 3 days	24th week	No
Secondary	final hair density	total count of hair in a 1cm-diametered circle	24th week	No