Dermis DensityTO-COSKINNCT04988412
The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters
A study testing Investigational product 1, Investigational product 2 and Investigational product 3 in people with Dermis Density and Wrinkles, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial summary
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM on skin in healthy human subjects in comparison to placebo product. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dermis Density, Wrinkles, Skin Hydration
- What is being tested?
- Investigational product 1, Investigational product 2 and Investigational product 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteSlovenia
- Study dates
- 11 Oct 2021to 21 Apr 2022
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
- Signed Informed consent form (ICF),
- Fitzpatrick skin phototypes I-IV,
- Signs of skin aging,
- In good general health condition,
- Body mass index (BMI) < 35
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- Willingness to avoid a consumption of any food supplements containing methylsulfonylmethane (MSM), antioxidants, collagen and other protein-based food supplements during the study,
- Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
- Willingness to maintain their living habits and to not begin or change any estrogen or progesterone therapies,
- Willingness to avoid shaving/depilation of their arms during the study,
- Willingness not to change cosmetic treatment routine during the study,
- Willingness to avoid rejuvenation treatments during the study.
Who cannot join
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products,
- Changes in dietary habits and dietary supplementation in the last three months prior to inclusion,
- Regular use of food supplements containing MSM, antioxidants, collagen or other protein-based food supplements in the last three months prior to inclusion,
- Veganism,
- Changes in cosmetic facial and body care routine in the last month prior to inclusion,
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- Diagnosed and uncontrolled/unregulated disease,
- Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, hematological disease,
- Intake of drugs with any impact on skin reactions (e.g., glucocorticoids, antihistamines, and immunomodulators),
- Any clinically significant acute or chronic skin diseases,
- Skin pigmentation disorders on measuring sites,
- Anticipated sunbathing or solarium visits before or during the study,
- Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels, laser therapy etc.) in the last 4 months prior to study entry,
- Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound, intense pulsed light therapy (IPL)) in the last month prior to study entry,
- Shaving/depilation of the arms in the last 14 days before inclusion,
- Mental incapacity that precludes adequate understanding or cooperation.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Higher School of Applied Sciences, Institute of Cosmetics
Ljubljana, 1000
About this study
Official title: The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Four-way Study Comparing the Efficacy of Three Test Products
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
Read the detailed description
This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center.
The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period.
Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.
- Conditions
- Dermis Density, Wrinkles, Skin Hydration, Trans Epidermal Water Loss (TEWL), Dermis Thickness, Skin Texture
- Being tested
- Investigational product 1, Placebo syrup, Investigational product 2, Investigational product 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational product 1Dietary supplement
Test group 1 will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
Placebo syrupDietary supplement
Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 12 weeks.
Investigational product 2Dietary supplement
Test group 2 will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
Investigational product 3Dietary supplement
Test group 3 will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CoMSM LD | Active comparator | Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). Receives: Dietary Supplement: Investigational product 1 |
| Placebo group | Placebo comparator | Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks. Receives: Dietary Supplement: Placebo syrup |
| Co HD | Active comparator | Participants will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL). Receives: Dietary Supplement: Investigational product 2 |
| CoMSM HD | Active comparator | Participants will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). Receives: Dietary Supplement: Investigational product 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
Significant change of dermis density from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.
Measured: 12 weeks
Secondary outcomes (6)
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Assessment of the effects of investigational product on periorbital wrinkles after 12 weeks of dietary supplementation will be done using topography measurements. Differences between test groups will also be evaluated.
Measured: 12 weeks
Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
For assessments of skin texture topography roughness measurements (Ra, Rq) will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated.
Measured: 12 weeks
Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle. Differences between test groups will also be evaluated.
Measured: 12 weeks
Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Assessment of the effects of investigational product on transepidermal water loss (TEWL) after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chamber principle.Differences between test groups will also be evaluated.
Measured: 12 weeks
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography. Differences between test groups will also be evaluated.
Measured: 12 weeks
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
For assessments of elasticity viscoelasticity measurements will be performed. Significant changes from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation is expected. Differences between test groups will also be evaluated. Along viscoelasticity the measurement sinchronosusly gives also retraction and Young modulus values, as well as U-values: Uf (final deformation), Ue (skin exstensibility), Uv (delayed distension), Ur (immediate retraction), Ua (total recovery). R5 (Ur/Ue) parameter will also be calculated.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start11 Oct 2021
- Primary completion21 Feb 2022
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermis DensityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tosla d.o.o., Slovenian Research Agency
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study director, Head of Reasearch Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988412
- Sponsor's protocol ID
- VIST TO-COSKIN 01-2021
- Acronym
- TO-COSKIN
- Status last verified
- Jan 2023
- First submitted
- 28 Jul 2021
- Last updated
- 2 Feb 2023
- 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12-week Dietary Intake of Food Supplements Containing Collagen on Dermis Density and Other Skin Parameters: Double Blind, Placebo-controlled, Randomised Four-way Study Comparing the Efficacy of Three Test Products
- ClinicalTrials.gov ID
- NCT04988412
- Acronym / sponsor ID
- TO-COSKIN / VIST TO-COSKIN 01-2021
- Conditions
- Dermis Density, Wrinkles, Skin Hydration, Trans Epidermal Water Loss (TEWL), Dermis Thickness, Skin Texture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- Tosla d.o.o., Slovenian Research Agency
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 3 Aug 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.
The aim of the randomized, double-blind, placebo-controlled, one-period effectiveness study is to compare the effects of multiple-dose 12 weeks daily dietary supplementation with 10 g collagen alone or 5 g or 10 g of collagen in combination with MSM on skin in healthy human subjects in comparison to placebo product. The main objective is to show that test products have beneficial effects on dermis density, and also on other skin parameters and to investigate differences in the effects among test products.
Detailed description
This is a double-blind, randomized, placebo-controlled four-way study comparing the efficacy of multiple-dose dietary intake of three test products on skin parameters, that will be conducted in Slovenia in one research center.
The study will be performed on 109 adult women, between the ages 40 and 65 years and will include daily dietary supplementation over 12-weeks period.
Subjects will be divided in four study groups . Test group 1 (TG1) will receive investigational product 1 (IP1, daily dose 25 mL: collagen 5 g, MSM: 1,5 g, vitamin C: 80 mg), test group 2 (TG2) will receive investigational product 2 (IP2, daily dose 25 mL: collagen 10 g, vitamin C: 80 mg), test group 3 (TG3) will receive investigational product 3 (TP3, daily dose 25 mL: collagen 10 g, MSM: 1,5 g, , vitamin C: 80 mg) and the placebo group (PG) will receive placebo product without those active ingredients (25 mL: 0 g collagen, 0 g MSM). Participants will test continuous administration of placebo or investigational products for 12 weeks in order to demonstrate and assess multiple-dose effects. Their influence on skin appendages via self-evaluations questionnaires will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CoMSM LD | Active comparator | Dietary Supplement: Investigational product 1Participants will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo syrupPlacebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, vitamin C: 0 mg); continous administration of placebo product for 12 weeks. |
| Co HD | Active comparator | Dietary Supplement: Investigational product 2Participants will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
| CoMSM HD | Active comparator | Dietary Supplement: Investigational product 3Participants will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
- Signed Informed consent form (ICF),
- Fitzpatrick skin phototypes I-IV,
- Signs of skin aging,
- In good general health condition,
Key exclusion criteria (16 listed)
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products,
- Changes in dietary habits and dietary supplementation in the last three months prior to inclusion,
- Regular use of food supplements containing MSM, antioxidants, collagen or other protein-based food supplements in the last three months prior to inclusion,
- Veganism,
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 |
|---|---|---|
| Investigational product 1Test group 1 will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. | Dietary supplement | CoMSM LD |
| Placebo syrupPlacebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 12 weeks. | Dietary supplement | Placebo group |
| Investigational product 2Test group 2 will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. | Dietary supplement | Co HD |
| Investigational product 3Test group 3 will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks. | Dietary supplement | CoMSM HD |
Primary outcome
Change of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Significant change of dermis density from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement. Differences in change of dermis density between test groups under primary objective conditions will also be evaluated.
6 secondary outcomes
Change of wrinkle volume from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Change of skin texture from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Change of skin hydration from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Change of TEWL from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Change of dermis thickness from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 12 weeks
Change of skin elasticity from baseline in test groups, in comparison to placebo group after 12 weeks of dietary supplementation
Time frame: 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 2 Feb 2023.
- 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.
Katja Žmitek, PhD study director
Head of Reasearch Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational product 1, Investigational product 2 and Investigational product 3 in people with Dermis Density and Wrinkles, run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
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 12 inclusion and 16 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 2 Feb 2023. 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 Slovenia. 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 of dermis density from baseline in all test groups in comparison to placebo group after 12 weeks of dietary supplementation (time frame: 12 weeks). 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 2 Feb 2023.