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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01548066
Other study ID # VPA_hair
Secondary ID
Status Completed
Phase Phase 2
First received July 20, 2011
Last updated October 5, 2012
Start date September 2011
Est. completion date June 2012

Study information

Verified date October 2012
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valproic Acid
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Control placebo
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Locations

Country Name City State
Korea, Republic of Department of Dermatology, Seoul National University Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Amorepacific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary linear hair growth rate the average growth rate of hair shaft for 3 days 24th week No
Secondary final hair density total count of hair in a 1cm-diametered circle 24th week No
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