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

Seoul National University logo

Seoul National University

Status and phase

Completed
Phase 2

Conditions

Male Pattern Baldness
Androgenetic Alopecia

Treatments

Drug: Valproic Acid
Drug: Control placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01548066
VPA_hair

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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