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

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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

Tracking Information
First Submitted Date  ICMJE July 20, 2011
First Posted Date  ICMJE March 8, 2012
Last Update Posted Date October 8, 2012
Study Start Date  ICMJE September 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
linear hair growth rate [ Time Frame: 24th week ]
the average growth rate of hair shaft for 3 days
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
final hair density [ Time Frame: 24th week ]
total count of hair in a 1cm-diametered circle
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Official Title  ICMJE The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Androgenetic Alopecia
  • Male Pattern Baldness
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01548066
Other Study ID Numbers  ICMJE VPA_hair
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Amorepacific Corporation
Investigators  ICMJE
Study Chair: Oh Sang Kwon, Prof. Seoul National Univeristy Hospital
Study Director: Seong Jin Jo, Fellow Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date October 2012

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