Dermis DensityQ10-collagenNCT03811756
The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
A study testing Test syrup containing CoQ10 and collagen in people with Dermis Density and Trans Epidermal Water Loss (TEWL), run by VIST - Faculty of Applied Sciences at 1 site in Slovenia.
Trial summary
Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults. One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50… 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, Trans Epidermal Water Loss (TEWL), Skin Hydration
- What is being tested?
- Test syrup containing CoQ10 and collagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Oct 2018to 10 Jul 2019
- 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 II and III,
- Signs of skin aging,
- In good health condition,
- Willingness to avoid a consumption of any food supplements containing CoQ10 and other antioxidants, collagen or vitamins during the study,
- Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).
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 last three months prior to inclusion,
- Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in last three months prior to inclusion,
- Veganism,
- Changes in cosmetic facial and body care routine in last month prior to inclusion,
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- Diagnosed and uncontrolled/untreated/unregulated disease,
- Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease,
- Acute skin diseases,
- Skin pigmentation disorders,
- Increased cholesterol and use of cholesterol lowering drugs (statins),
- Anticipated sunbathing or solarium visits before or during the study,
- Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
- Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
- 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 Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters: Randomised Double-blind Placebo-controlled Study
Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.
One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.
- Conditions
- Dermis Density, Trans Epidermal Water Loss (TEWL), Skin Hydration, Wrinkles, Dermis Thickness
- Being tested
- Test syrup containing CoQ10 and collagen, Placebo syrup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test syrup containing CoQ10 and collagenDietary supplement
Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.
Placebo syrupDietary supplement
Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | Participants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg). Receives: Dietary Supplement: Test syrup containing CoQ10 and collagen |
| Placebo group | Placebo comparator | Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks. Receives: Dietary Supplement: Placebo syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Significant change of dermis density 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 through ultrasonographic dermis intensity measurement.
Measured: 12 weeks
Secondary outcomes (5)
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
For assessments of skin viscoelasticity measurements will be performed. Significant change of skin viscoeasticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
Measured: 12 weeks
Influence of the investigational product in relation to placebo product on skin hydration
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.
Measured: 12 weeks
Influence of the investigational product in relation to placebo product on TEWL
Assessment of the effects of investigational product on transepidermal water loss after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chambre principle.
Measured: 12 weeks
Influence of investigational product in relation to placebo product on dermis thickness
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.
Measured: 12 weeks
Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements
Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements.
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 posted22 Jan 2019
- Study start15 Oct 2018
- Primary completion19 Feb 2019
- Study completion10 Jul 2019
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- European Regional Development Fund, Valens Int. d.o.o., Slovenija, Ministry of Higher Education, Science and Technology, Solvenia
- Responsible party
- Sponsor
- Investigators
- Katja Žmitek, PhD, Study director, Head of Reasearch Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811756
- Sponsor's protocol ID
- VIST F4F Q10-collagen 01-2018
- Acronym
- Q10-collagen
- Status last verified
- Dec 2019
- First submitted
- 17 Jan 2019
- Last updated
- 14 Oct 2021
- 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 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters: Randomised Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03811756
- Acronym / sponsor ID
- Q10-collagen / VIST F4F Q10-collagen 01-2018
- Conditions
- Dermis Density, Trans Epidermal Water Loss (TEWL), Skin Hydration, Wrinkles, Dermis Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- European Regional Development Fund, Valens Int. d.o.o., Slovenija, Ministry of Higher Education, Science and Technology, Solvenia
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 19 Feb 2019 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 22 Jan 2019 (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.
Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.
One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.
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 |
|---|---|---|
| Test group | Active comparator | Dietary Supplement: Test syrup containing CoQ10 and collagenParticipants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg). |
| 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, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 II and III,
- Signs of skin aging,
- In good health condition,
Key exclusion criteria (15 listed)
- Pregnancy or breastfeeding,
- Known or suspected allergy to any ingredient of the tested products,
- Changes in dietary habits and dietary supplementation in last three months prior to inclusion,
- Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in 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 |
|---|---|---|
| Test syrup containing CoQ10 and collagenTest group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks. | Dietary supplement | Test group |
| Placebo syrupPlacebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks. | Dietary supplement | Placebo group |
Primary outcome
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
Time frame: 12 weeks
Significant change of dermis density 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 through ultrasonographic dermis intensity measurement.
5 secondary outcomes
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
Time frame: 12 weeks
Influence of the investigational product in relation to placebo product on skin hydration
Time frame: 12 weeks
Influence of the investigational product in relation to placebo product on TEWL
Time frame: 12 weeks
Influence of investigational product in relation to placebo product on dermis thickness
Time frame: 12 weeks
Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements
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 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Dermis Density
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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 Test syrup containing CoQ10 and collagen in people with Dermis Density and Trans Epidermal Water Loss (TEWL), 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 7 inclusion and 15 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 14 Oct 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 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?
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement (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 14 Oct 2021.