The Efficacy and Safety of Topical Valproic Acid in Preve... | NCT01548066

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

NCT01548066

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Oct 8, 2012Estimated

Enrollment

40Actual

Phase

Phase 2

Conditions

Androgenetic Alopecia
Male Pattern Baldness

Interventions

Valproic Acid
Control placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

May 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Jul 20, 2011

First Submission Date that Met QC Criteria

Mar 7, 2012

First Posted Date

Mar 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 5, 2012

Last Update Posted Date

Oct 8, 2012Estimated

Name	Class
Amorepacific Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium valproate	Experimental	spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks	Drug: Valproic Acid
Control	Placebo Comparator	spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks	Drug: Control placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Valproic Acid	Drug	spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks	Sodium valproate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
linear hair growth rate	the average growth rate of hair shaft for 3 days	24th week

Secondary Outcomes

Measure	Description	Time Frame
final hair density	total count of hair in a 1cm-diametered circle	24th week

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oh Sang Kwon, Prof.	Seoul National Univeristy Hospital	Study Chair
Seong Jin Jo, Fellow	Seoul National University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Dermatology, Seoul National University Hospital		Seoul		110-744	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014635	Valproic Acid

Ancestor Terms

ID	Term
D010421	Pentanoic Acids
D014631	Valerates
D000144	Acids, Acyclic
D002264	Carboxylic Acids

Browse Leaves

Not provided

Browse Branches

Not provided