Skin ManifestationsNCT03505684
Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
A study testing CTP in people with Skin Manifestations and Skin Wrinkling, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations, Skin Wrinkling
- What is being tested?
- CTP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2017to 30 Jul 2018
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- > = 4 of Tewameter
Who cannot join
- Within the last 6 months, took skin surgery including cosmetic purpose
- Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- Creatinine levels: more than twice the normal upper limit
- AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
- Uncontrolled hypertension
- sun allergy or sensitive skin
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- functional cosmetics that affect dermal moistures and wrinkles within the last 3 months.
- If you have participated or are planning to participate in another clinical trial within the past month
- Alcohol abuser
- If they are pregnant or lactating or have a pregnancy plan during the clinical trial Those with allergic reactions to the constituent food
- Any person deemed inappropriate by the researcher for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Integrated Research Institute for Natural Ingredients and Functional Foods
Yangsan, 50612
About this study
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants
Read the detailed description
The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants by a randomized, double-blind, and control-group study.
- Conditions
- Skin Manifestations, Skin Wrinkling
- Being tested
- CTP, placebo (starch)
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTPDietary supplement
1,000 mg of CTP was orally administered per day for 12 weeks.
placebo (starch)Dietary supplement
placebo (starch)
| Study group | Role | What they receive |
|---|---|---|
| CTP group | Experimental | 1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks. Receives: Dietary Supplement: CTP |
| Control group | Placebo comparator | 1,000 mg of placebo (starch) was orally administered per day for 12 weeks Receives: Dietary Supplement: placebo (starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in Transepidermal Waterloss by Tewameter
comparison between baseline, after 6 weeks, and after 12 weeks
Measured: baseline, after 6 weeks, and after 12 weeks
Secondary outcomes (3)
changes in skin wrinkling indices by Visiometer
comparison between baseline, after 6 weeks, and after 12 weeks
Measured: baseline, after 6 weeks, and after 12 weeks
skin elasticity by Cutometer
comparison between baseline, after 6 weeks, and after 12 weeks
Measured: baseline, after 6 weeks, and after 12 weeks
changes in hydration level of the skin surface by Corneometer
comparison between baseline, after 6 weeks, and after 12 weeks
Measured: baseline, after 6 weeks, and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start24 Dec 2017
- Primary completion15 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ManifestationsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, MD, Principal investigator, Integrated Research Institute for Natural Ingredients and Functional Foods
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505684
- Sponsor's protocol ID
- 02-2017-033
- Status last verified
- Aug 2018
- First submitted
- 13 Apr 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tak YJ, Shin DK, Kim AH, Kim JI, Lee YL, Ko HC, Kim YW, Lee SY. Effect of Collagen Tripeptide and Adjusting for Climate Change on Skin Hydration in Middle-Aged Women: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jan 11;7:608903. doi: 10.3389/fmed.2020.608903. eCollection 2020.
PubMed 33521019
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Collagen Tripeptide on Skin Moisture and Wrinkles in Adult Women
- ClinicalTrials.gov ID
- NCT03505684
- Acronym / sponsor ID
- 02-2017-033
- Conditions
- Skin Manifestations, Skin Wrinkling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 24 Dec 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 23 Apr 2018 (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.
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants
Detailed description
The aim is to investigate the effect of oral ingestion of collagen tripeptides derived from fish on dermal moistures and wrinkles body fat reduction in participants by a randomized, double-blind, and control-group study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTP group | Experimental | Dietary Supplement: CTP1,000 mg of collagen tripeptide (CTP) was orally administered per day for 12 weeks. |
| Control group | Placebo comparator | Dietary Supplement: placebo (starch)1,000 mg of placebo (starch) was orally administered per day for 12 weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- > = 4 of Tewameter
Key exclusion criteria (11 listed)
- Within the last 6 months, took skin surgery including cosmetic purpose
- Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- Creatinine levels: more than twice the normal upper limit
- AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
- Uncontrolled hypertension
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 |
|---|---|---|
| CTP1,000 mg of CTP was orally administered per day for 12 weeks. | Dietary supplement | CTP group |
| placebo (starch)placebo (starch) | Dietary supplement | Control group |
Primary outcome
changes in Transepidermal Waterloss by Tewameter
Time frame: baseline, after 6 weeks, and after 12 weeks
comparison between baseline, after 6 weeks, and after 12 weeks
3 secondary outcomes
changes in skin wrinkling indices by Visiometer
Time frame: baseline, after 6 weeks, and after 12 weeks
skin elasticity by Cutometer
Time frame: baseline, after 6 weeks, and after 12 weeks
changes in hydration level of the skin surface by Corneometer
Time frame: baseline, after 6 weeks, and after 12 weeks
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 28 Aug 2018.
- Derived from this study: PubMed 33521019Tak YJ, Shin DK, Kim AH, Kim JI, Lee YL, Ko HC, Kim YW, Lee SY. Effect of Collagen Tripeptide and Adjusting for Climate Change on Skin Hydration in Middle-Aged Women: A Randomized, Double-Blind, Placebo-Controlled Trial. Front Med (Lausanne). 2021 Jan 11;7:608903. doi: 10.3389/fmed.2020.608903. eCollection 2020.
- 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.
Sang Yeoup Lee, MD principal investigator
Integrated Research Institute for Natural Ingredients and Functional Foods
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTP in people with Skin Manifestations and Skin Wrinkling, run by Pusan National University Yangsan 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 1 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 28 Aug 2018. 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?
changes in Transepidermal Waterloss by Tewameter (time frame: baseline, after 6 weeks, and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03505684, which also lists 1 linked publication.
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 28 Aug 2018.