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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548066

Enrollment

Registered

2012-03-08

Start date

2011-09-30

Completion date

2012-06-30

Last updated

2012-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia, Male Pattern Baldness

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.

Interventions

DRUGValproic Acid

spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks

DRUGControl placebo

spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026