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

NCT01548066 | Completed Phase 2

• 1 other identifier: VPA_hair
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Androgenetic Alopecia; Male Pattern Baldness

Outcome Measures

Primary Outcomes (1)

• linear hair growth rate

  the average growth rate of hair shaft for 3 days

  24th week

Secondary Outcomes (1)

• final hair density

  24th week

Study Arms (2)

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

Valproic Acid DRUG

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

Sodium valproate

Control placebo DRUG

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

Control

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 19 years \~ 45 years
• subjects with AGA (Hamilton\&Norwood grad III\~IV)
• subjects who are able to be followed for next 24 weeks.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Amorepacific Corporation: collaborator

Study Sites (1)

Department of Dermatology, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Alopecia

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Oh Sang Kwon, Prof.

  Seoul National Univeristy Hospital

  STUDY CHAIR

• Seong Jin Jo, Fellow

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: March 8, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 8, 2012

Record last verified: 2012-10

Locations

KR (1)