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

Phase 2

Completed

• Conditions: Androgenetic Alopecia; Male Pattern Baldness
• Interventions: Drug: Valproic Acid; Drug: Control placebo

• Registration Number: NCT01548066
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-20
• Study Start: 2011-09
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-05
• Last Update Posted: 2012-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium valproate	Valproic Acid	spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Control	Control placebo	spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Primary Outcome Measures

Name	Time	Method
linear hair growth rate	24th week	the average growth rate of hair shaft for 3 days

Secondary Outcome Measures

Name	Time	Method
final hair density	24th week	total count of hair in a 1cm-diametered circle

Trial Locations

Locations (1)

Department of Dermatology, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of