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

This study has been completed.
Sponsor:
Collaborator:
Amorepacific Corporation
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01548066
First received: July 20, 2011
Last updated: October 5, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Androgenetic Alopecia
Male Pattern Baldness
 Drug: Valproic Acid
Drug: Control placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • linear hair growth rate [ Time Frame: 24th week ] [ Designated as safety issue: No ]
    the average growth rate of hair shaft for 3 days


Secondary Outcome Measures:
  • final hair density [ Time Frame: 24th week ] [ Designated as safety issue: No ]
    total count of hair in a 1cm-diametered circle


Enrollment: 40
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548066

Locations
Korea, Republic of
Department of Dermatology, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Amorepacific Corporation
Investigators
Study Chair: Oh Sang Kwon, Prof. Seoul National Univeristy Hospital
Study Director: Seong Jin Jo, Fellow Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01548066     History of Changes
Other Study ID Numbers: VPA_hair
Study First Received: July 20, 2011
Last Updated: October 5, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 21, 2013