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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia; Male Pattern Baldness
• Intervention / Treatment: Drug: Valproic Acid; Drug: Control placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Department of Dermatology, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium valproate; spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks	Drug: Valproic Acid; spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Placebo Comparator: Control; spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks	Drug: Control placebo; spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
linear hair growth rate	the average growth rate of hair shaft for 3 days	24th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
final hair density	total count of hair in a 1cm-diametered circle	24th week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Amorepacific Corporation
• Investigators: Study Chair: Oh Sang Kwon, Prof., Seoul National Univeristy Hospital; Study Director: Seong Jin Jo, Fellow, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 20, 2011
• First Submitted That Met QC Criteria: March 7, 2012
• First Posted (Estimate): March 8, 2012

Study Record Updates

• Last Update Posted (Estimate): October 8, 2012
• Last Update Submitted That Met QC Criteria: October 5, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; GABA Agents; Anticonvulsants; Antimanic Agents; Valproic Acid
• Other Study ID Numbers: VPA_hair