Hair DamageNCT06422026
Evaluated the Efficacy and Safety of APCP on Hair Health
A study testing APCP I and APCP II in people with Hair Damage, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Damage
- What is being tested?
- APCP I and APCP II
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2023to 30 Apr 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
- A person capable of maintaining the same hair shape and color during this human body application test
- A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
Who cannot join
- A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
- As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
- A person who plans to manage and operate hair supplies, hair products during this human body application test
- A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
- A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
- Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
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- A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
- A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
- A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
- A person who is sensitive to or allergic to food ingredients for this human body application test
- A person who is deemed inappropriate by the tester for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health
This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
- Conditions
- Hair Damage
- Being tested
- APCP I, APCP II, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APCP IDietary supplement
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g.
APCP IIDietary supplement
Each subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g.
PlaceboDietary supplement
Each subject takes one active bottle per day for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| APCP I | Active comparator | Not described Receives: Dietary Supplement: APCP I |
| APCP II | Active comparator | Not described Receives: Dietary Supplement: APCP II |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hair tensile strength
Hair tensile strength measured by UTM(Universal Testing Machine) etc.
Measured: Baseline, 24 week
Secondary outcomes (6)
Change from baseline in hair gloss
Hair gloss measured by Glossymeter etc.
Measured: Baseline, 24 week
Change from baseline in hair density
Hair density measured by Folliscope
Measured: Baseline, 24 week
Change from baseline in hair volume
Hair volume measured by I Max-plus
Measured: Baseline, 24 week
Change from baseline in satisfaction survey
Satisfaction surveys are evaluated on a 10-point scale. Survey items are evaluated on a scale from '0 - Not at all' to '10 - Very much so' (although scoring may be reversed depending on the question).
Measured: Baseline, 24 week
Change from baseline in scalp moisture
scalp moisture measured by DermaLab Hydration Pin Probe
Measured: Baseline, 24 week
Change from baseline in scalp percutaneous moisture loss
scalp percutaneous moisture loss measured by Tewameter TM Nano
Measured: Baseline, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start16 Mar 2023
- Primary completion30 Jan 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair DamageStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422026
- Sponsor's protocol ID
- AP-PV-2022-02
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of APCP on Hair Health
- ClinicalTrials.gov ID
- NCT06422026
- Acronym / sponsor ID
- AP-PV-2022-02
- Conditions
- Hair Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 May 2024 (actual)
- 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.
This study is designed to evaluate the efficacy and safety of APCP in promoting hair health in adult with mild to moderate hair damage, compared to a placebo control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APCP I | Active comparator | Dietary Supplement: APCP I |
| APCP II | Active comparator | Dietary Supplement: APCP II |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
- A person capable of maintaining the same hair shape and color during this human body application test
- A person who has agreed to participate in this human application test before the start of the human application test and filled out the Informed Consent Form
Key exclusion criteria (11 listed)
- A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
- As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
- A person who plans to manage and operate hair supplies, hair products during this human body application test
- A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
- A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
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 |
|---|---|---|
| APCP IEach subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 3 g. | Dietary supplement | APCP I |
| APCP IIEach subject takes one active bottle per day for 24 weeks. Each bottle contains APCP 4 g. | Dietary supplement | APCP II |
| PlaceboEach subject takes one active bottle per day for 24 weeks. | Dietary supplement | Placebo |
Primary outcome
Change from baseline in hair tensile strength
Time frame: Baseline, 24 week
Hair tensile strength measured by UTM(Universal Testing Machine) etc.
6 secondary outcomes
Change from baseline in hair gloss
Time frame: Baseline, 24 week
Change from baseline in hair density
Time frame: Baseline, 24 week
Change from baseline in hair volume
Time frame: Baseline, 24 week
Change from baseline in satisfaction survey
Time frame: Baseline, 24 week
Change from baseline in scalp moisture
Time frame: Baseline, 24 week
Change from baseline in scalp percutaneous moisture loss
Time frame: Baseline, 24 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 22 May 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APCP I and APCP II in people with Hair Damage, run by Amorepacific Corporation 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 11 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 22 May 2024. 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.
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?
Change from baseline in hair tensile strength (time frame: Baseline, 24 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 22 May 2024.