Back to resultsThe Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Primary Purpose
Androgenetic Alopecia, Male Pattern Baldness
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Valproic Acid
Control placebo
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility 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
Sites / Locations
- Department of Dermatology, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sodium valproate
Control
Arm Description
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Outcomes
Primary Outcome Measures
linear hair growth rate
the average growth rate of hair shaft for 3 days
Secondary Outcome Measures
final hair density
total count of hair in a 1cm-diametered circle
Full Information
NCT ID
NCT01548066
First Posted
July 20, 2011
Last Updated
October 5, 2012
Sponsor
Seoul National University Hospital
Collaborators
Amorepacific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01548066
Brief Title
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Official Title
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Amorepacific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia, Male Pattern Baldness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium valproate
Arm Type
Experimental
Arm Description
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Valproic Acid
Intervention Description
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Control placebo
Intervention Description
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Primary Outcome Measure Information:
Title
linear hair growth rate
Description
the average growth rate of hair shaft for 3 days
Time Frame
24th week
Secondary Outcome Measure Information:
Title
final hair density
Description
total count of hair in a 1cm-diametered circle
Time Frame
24th week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Sang Kwon, Prof.
Organizational Affiliation
Seoul National Univeristy Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seong Jin Jo, Fellow
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
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