MedDataX Logo

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

NCT ID: NCT01548066

Last Updated: 2012-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Androgenetic Alopecia Male Pattern Baldness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sodium valproate

spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Group Type EXPERIMENTAL

Valproic Acid

Intervention Type DRUG

spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Control

spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Group Type PLACEBO_COMPARATOR

Control placebo

Intervention Type DRUG

spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valproic Acid

spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Intervention Type DRUG

Control placebo

spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amorepacific Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oh Sang Kwon, Prof.

Role: STUDY_CHAIR

Seoul National Univeristy Hospital

Seong Jin Jo, Fellow

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Dermatology, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VPA_hair

Identifier Type: -

Identifier Source: org_study_id