Dry SkinNCT05059197
Efficacy and Safety of AP Collagen Peptide on the Skin
A study testing AP collagen peptide in people with Dry Skin, run by Amorepacific Corporation at 1 site in South Korea.
Trial summary
This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Skin
- What is being tested?
- AP collagen peptide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2020to 12 Oct 2021
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those whose eye wrinkles are Grade 3 or higher in the visual evaluation
- Those whose moisture retention in both cheeks measured by Corneometer® is 49 A.U. or less
- 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
- Those with skin diseases such as atopic dermatitis and psoriasis
- Those who are sensitive to or allergic to the food ingredients for this trial foods
- Those with skin abnormalities such as spots, acne, erythema, and hypersensitive skin at the test site
- People who take diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month based on visit1
- Those who have used functional cosmetics for wrinkle improvement, highly moisturizing cosmetics, or skincare devices within 2 weeks of visit 1
- A person who used steroid-containing outer skin for more than one month to treat skin diseases
Show all 9Show fewer
- A person who has received chemical and physical treatment (pattern, epidermis, lasers, procedures, etc.) in the test area within six months prior to the start of the test
- Visit 1 A person who has participated in other interventional clinical tests (including human application tests) within one month of the standard or plans to participate in other interventional clinical tests (including human application tests) after the start of this human application test
- A person who judges that the tester is inappropriate for this test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Skin Health Improvement and Safety in AP Collagen Peptide: Randomized, Double-blind, Placebo-controlled
This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks.
- Conditions
- Dry Skin
- Being tested
- AP collagen peptide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP collagen peptideDietary supplement
Health functional food
PlaceboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| AP collagen peptide | Experimental | Each subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg Receives: Dietary Supplement: AP collagen peptide |
| Placebo | Placebo comparator | Each subject takes one active bottle per day for 12 weeks. 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 epidermal hydration
skin hydration measured by MoistureMeter-D compact
Measured: Baseline, 12 week
Secondary outcomes (6)
Change from baseline in skin roughness (texture)
skin roughness measured by PRIMOS
Measured: Baseline, 12 week
Change from baseline in skin gloss
skin roughness measured by Skinglossmeter
Measured: Baseline, 12 week
Change from baseline in stratum corneum condition
stripped using 10 tape strips (D-Squame) and measured by VisioScan
Measured: Baseline, 12 week
Change of Ceramides in stratum corneum
ultra-performance liquid chromatography system etc.
Measured: Baseline, 12 week
Change of Natural moisturizing factor in stratum corneum
Ultra-performance liquid chromatography system etc.
Measured: Baseline, 12 week
Change from baseline in TEWL
Transepidermal water loss measured by vapometer
Measured: Baseline, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start15 Dec 2020
- Primary completion30 Sep 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SkinStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hae Kwang Lee, PhD, Principal investigator, P&K Skin Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059197
- Sponsor's protocol ID
- PNK-20D21-FF1R
- Status last verified
- Sep 2021
- First submitted
- 17 Sep 2021
- Last updated
- 11 Nov 2021
- Results posted
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin Health Improvement and Safety in AP Collagen Peptide: Randomized, Double-blind, Placebo-controlled
- ClinicalTrials.gov ID
- NCT05059197
- Acronym / sponsor ID
- PNK-20D21-FF1R
- Conditions
- Dry Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 28 Sep 2021 (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 double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on improving skin health. Subjects with dried skin were randomly assigned to receive placebo or APCP once daily for 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP collagen peptide | Experimental | Dietary Supplement: AP collagen peptideEach subject takes one active bottle per day for 12 weeks. Each bottle contains AP collagen 1000 mg |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach subject takes one active bottle per day for 12 weeks. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Those whose eye wrinkles are Grade 3 or higher in the visual evaluation
- Those whose moisture retention in both cheeks measured by Corneometer® is 49 A.U. or less
- 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 (9 listed)
- Those with skin diseases such as atopic dermatitis and psoriasis
- Those who are sensitive to or allergic to the food ingredients for this trial foods
- Those with skin abnormalities such as spots, acne, erythema, and hypersensitive skin at the test site
- People who take diet pills (absorbent and antidepressants, appetite suppressants, etc.) and contraceptives or hormones or diuretics within one month based on visit1
- Those who have used functional cosmetics for wrinkle improvement, highly moisturizing cosmetics, or skincare devices within 2 weeks 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 |
|---|---|---|
| AP collagen peptideHealth functional food | Dietary supplement | AP collagen peptide |
| Placeboplacebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in epidermal hydration
Time frame: Baseline, 12 week
skin hydration measured by MoistureMeter-D compact
6 secondary outcomes
Change from baseline in skin roughness (texture)
Time frame: Baseline, 12 week
Change from baseline in skin gloss
Time frame: Baseline, 12 week
Change from baseline in stratum corneum condition
Time frame: Baseline, 12 week
Change of Ceramides in stratum corneum
Time frame: Baseline, 12 week
Change of Natural moisturizing factor in stratum corneum
Time frame: Baseline, 12 week
Change from baseline in TEWL
Time frame: Baseline, 12 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 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Hae Kwang Lee, PhD principal investigator
P&K Skin Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AP collagen peptide in people with Dry Skin, 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 9 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 11 Nov 2021. 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 epidermal hydration (time frame: Baseline, 12 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 11 Nov 2021.