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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

July 20, 2011
October 5, 2012
September 2011
May 2012   (final data collection date for primary outcome measure)
linear hair growth rate [ Time Frame: 24th week ] [ Designated as safety issue: No ]
the average growth rate of hair shaft for 3 days
Same as current
Complete list of historical versions of study NCT01548066 on ClinicalTrials.gov Archive Site
final hair density [ Time Frame: 24th week ] [ Designated as safety issue: No ]
total count of hair in a 1cm-diametered circle
Same as current
Not Provided
Not Provided
 
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Androgenetic Alopecia
  • Male Pattern Baldness
  • Drug: Valproic Acid
    spray 7.2% of 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
  • Experimental: Sodium valproate
    spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
    Intervention: Drug: Valproic Acid
  • Placebo Comparator: Control
    spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
    Intervention: Drug: Control placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2012
May 2012   (final data collection date for primary outcome measure)

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
Male
19 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01548066
VPA_hair
No
Seoul National University Hospital
Seoul National University Hospital
Amorepacific Corporation
Study Chair: Oh Sang Kwon, Prof. Seoul National Univeristy Hospital
Study Director: Seong Jin Jo, Fellow Seoul National University Hospital
Seoul National University Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP