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OpenTrials
Completed

NCT Number: NCT01548066

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Male Pattern Baldness Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Dermatology, Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valproic acid

Drug

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

Control placebo

Drug

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

Primary outcomes

  1. linear hair growth rate

    Time frame: 24th week

    the average growth rate of hair shaft for 3 days

Secondary outcomes

  1. final hair density

    Time frame: 24th week

    total count of hair in a 1cm-diametered circle

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Amorepacific Corporation

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Oct 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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