Androgenetic AlopeciaPhase 2NCT01548066
The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
A Phase 2 study testing Valproic Acid in people with Androgenetic Alopecia and Male Pattern Baldness, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Male Pattern Baldness
- What is being tested?
- Valproic Acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 19 years ~ 45 years
- subjects with AGA (Hamilton\&Norwood grad III~IV)
- subjects who are able to be followed for next 24 weeks.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Seoul National University Hospital
Seoul, 110-744
About this study
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
- Being tested
- Valproic Acid, Control placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
Control placeboDrug
spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sodium valproate | Experimental | spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks Receives: Drug: Valproic Acid |
| Control | Placebo comparator | spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks Receives: Drug: Control placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear hair growth rate
the average growth rate of hair shaft for 3 days
Measured: 24th week
Secondary outcomes (1)
final hair density
total count of hair in a 1cm-diametered circle
Measured: 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amorepacific Corporation
- Responsible party
- Sponsor
- Investigators
- Oh Sang Kwon, Prof., Study chair, Seoul National Univeristy HospitalSeong Jin Jo, Fellow, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548066
- Sponsor's protocol ID
- VPA_hair
- Status last verified
- Oct 2012
- First submitted
- 20 Jul 2011
- Last updated
- 8 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss
- ClinicalTrials.gov ID
- NCT01548066
- Acronym / sponsor ID
- VPA_hair
- Conditions
- Androgenetic Alopecia, Male Pattern Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Amorepacific Corporation
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium valproate | Experimental | Drug: Valproic Acidspray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks |
| Control | Placebo comparator | Drug: Control placebospray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age: 19 years ~ 45 years
- subjects with AGA (Hamilton\&Norwood grad III~IV)
- subjects who are able to be followed for next 24 weeks.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic Acidspray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks | Drug | Sodium valproate |
| Control placebospray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks | Drug | Control |
Primary outcome
linear hair growth rate
Time frame: 24th week
the average growth rate of hair shaft for 3 days
1 secondary outcome
final hair density
Time frame: 24th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2012.
Related trials for Androgenetic Alopecia
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Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
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Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
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Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Sang Kwon, Prof. study chair
Seoul National Univeristy Hospital
Seong Jin Jo, Fellow study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid in people with Androgenetic Alopecia and Male Pattern Baldness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
linear hair growth rate (time frame: 24th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2012.