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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01548066
Recruitment Status : Completed
First Posted : March 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Collaborator:
Amorepacific Corporation
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Male Pattern Baldness Drug: Valproic Acid Drug: Control placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. linear hair growth rate [ Time Frame: 24th week ]
    the average growth rate of hair shaft for 3 days


Secondary Outcome Measures :
  1. final hair density [ Time Frame: 24th week ]
    total count of hair in a 1cm-diametered circle


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548066


Locations
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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
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Study Chair: Oh Sang Kwon, Prof. Seoul National Univeristy Hospital
Study Director: Seong Jin Jo, Fellow Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01548066    
Other Study ID Numbers: VPA_hair
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Valproic Acid
Anticonvulsants
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