WrinklesNCT02604641
Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin
A study testing Quvital LD group and Quvital HD group in people with Wrinkles and Ageing, run by VIST - Faculty of Applied Sciences.
Trial summary
Objective of the study is to determine the influence of dietary supplementation with coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per… Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkles, Ageing, Photoprotection
- What is being tested?
- Quvital LD group and Quvital HD group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2015
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signs of skin aging (mimic wrinkles/ poor skin tone/ visual dryness),
- Photoaged skin on the face,
- Expression of mimic wrinkles,
- Phototype II and III.
Who cannot join
- Allergy to ingredients of tested products
- High blood cholesterol and use of cholesterol-lowering medicines,
- Diagnosed diabetes
- Thyroid disease
- Inflammatory skin diseases,
- Regular use of dietary supplements 6 months or less before start of the study,
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- Invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study,
- Non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 6 months or less prior to start of the study,
- The use of cosmetic products containing coenzyme Q10 6 months or less prior to start of the study,
- Gluteal hyperpigmentation,
- Expected sunbathing (also in solariums) within the study period.
About this study
Official title: Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study
Objective of the study is to determine the influence of dietary supplementation with coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. Various skin parameters will be evaluated before the supplementation (the baseline), after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the supplementation.
Read the detailed description
Objective of the study is to determine the influence of dietary supplementation of CoQ10 in form of water-soluble Q10vital® on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. The placebo or CoQ10 will be administered in the form of a syrup; all subjects will consume 5 mL of syrup daily for 12 weeks. The photoprotective potential of CoQ10 will be evaluated with a determination of the minimal erythema dose (MED) before (the baseline) and after 12 weeks of the supplementation. Other skin parameters will be evaluated before supplementation (the baseline), after 6 and after 12 weeks of supplementation. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.
- Conditions
- Wrinkles, Ageing, Photoprotection
- Being tested
- Placebo group, Quvital LD group, Quvital HD group
- Keywords
- skin rejuvenation, anti-ageing effects, minimal erythema dose, dermis structure, physiological skin condition, wrinkling, dry skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo groupDietary supplement
Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.
Quvital LD groupDietary supplement
Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.
Quvital HD groupDietary supplement
Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | 0 mg CoQ10 daily Receives: Dietary Supplement: Placebo group |
| Quvital LD group | Active comparator | 50 mg CoQ10 daily Receives: Dietary Supplement: Quvital LD group |
| Quvital HD group | Active comparator | 150 mg CoQ10 daily Receives: Dietary Supplement: Quvital HD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of photoprotective function of the skin
Minimal erythema dose (MED) of the skin will be determined. Skin on gluteal part of the body will be exposed to 10 different doses of UVB light and 24 hours after exposure MED will be determined.Higher MED indicates better photoprotective function of the skin.
Measured: after 12 weeks of the supplementation
Secondary outcomes (5)
Reduction of the area of the periorbital facial wrinkles
Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Measured: after 6 and after 12 weeks of the supplementation
Reduction of the volume of the periorbital facial wrinkles
Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.
Measured: after 6 and after 12 weeks of the supplementation
Reduction of wrinkles at different face areas
Expert assessment of wrinkles at different face areas (periorbital, frontal, glabelar, nasolabial areas etc.) will be done according to Lemperle Wrinkle assessment scale.
Measured: after 6 and after 12 weeks of the supplementation
Improvement of the dermis structure
Ultrasound (US) images of the dermis will be taken and intensity of the dermis determined. Higher intensity of the dermis US images indicates improvement of the collagen and elastin network.
Measured: after 6 and after 12 weeks of the supplementation
An increase of the dermis thickness
Dermis thickness will be measured with ultrasound imaging of the skin.
Measured: after 6 and 12 weeks of the supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIST - Faculty of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Valens Int. d.o.o., Slovenija, Institute of Nutrition, Slovenia (Nutris)
- Responsible party
- Sponsor
- Investigators
- Janko Zmitek, PhD, Study chair, VIST - Faculty of Applied SciencesKatja Zmitek, PhD, Study director, VIST - Faculty of Applied SciencesLiljana Mervic, PhD, Study chair, UL MFTina Tina Pogačnik, BSc, Principal investigator, VIST - Faculty of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604641
- Sponsor's protocol ID
- Q10 01-2014
- Status last verified
- Oct 2021
- First submitted
- 4 Nov 2015
- Last updated
- 8 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 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02604641
- Acronym / sponsor ID
- Q10 01-2014
- Conditions
- Wrinkles, Ageing, Photoprotection
- Keywords
- skin rejuvenation, anti-ageing effects, minimal erythema dose, dermis structure, physiological skin condition, wrinkling, dry skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- VIST - Faculty of Applied SciencesUniversity, hospital or other
- Collaborators
- Valens Int. d.o.o., Slovenija, Institute of Nutrition, Slovenia (Nutris)
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Nov 2015 (estimated)
- 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.
Objective of the study is to determine the influence of dietary supplementation with coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. Various skin parameters will be evaluated before the supplementation (the baseline), after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the supplementation.
Detailed description
Objective of the study is to determine the influence of dietary supplementation of CoQ10 in form of water-soluble Q10vital® on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. The placebo or CoQ10 will be administered in the form of a syrup; all subjects will consume 5 mL of syrup daily for 12 weeks. The photoprotective potential of CoQ10 will be evaluated with a determination of the minimal erythema dose (MED) before (the baseline) and after 12 weeks of the supplementation. Other skin parameters will be evaluated before supplementation (the baseline), after 6 and after 12 weeks of supplementation. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.
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 |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Placebo group0 mg CoQ10 daily |
| Quvital LD group | Active comparator | Dietary Supplement: Quvital LD group50 mg CoQ10 daily |
| Quvital HD group | Active comparator | Dietary Supplement: Quvital HD group150 mg CoQ10 daily |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signs of skin aging (mimic wrinkles/ poor skin tone/ visual dryness),
- Photoaged skin on the face,
- Expression of mimic wrinkles,
- Phototype II and III.
Key exclusion criteria (11 listed)
- Allergy to ingredients of tested products
- High blood cholesterol and use of cholesterol-lowering medicines,
- Diagnosed diabetes
- Thyroid disease
- Inflammatory skin diseases,
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 |
|---|---|---|
| Placebo groupSubjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks. | Dietary supplement | Placebo group |
| Quvital LD groupSubjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks. | Dietary supplement | Quvital LD group |
| Quvital HD groupSubjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks. | Dietary supplement | Quvital HD group |
Primary outcome
Improvement of photoprotective function of the skin
Time frame: after 12 weeks of the supplementation
Minimal erythema dose (MED) of the skin will be determined. Skin on gluteal part of the body will be exposed to 10 different doses of UVB light and 24 hours after exposure MED will be determined.Higher MED indicates better photoprotective function of the skin.
5 secondary outcomes
Reduction of the area of the periorbital facial wrinkles
Time frame: after 6 and after 12 weeks of the supplementation
Reduction of the volume of the periorbital facial wrinkles
Time frame: after 6 and after 12 weeks of the supplementation
Reduction of wrinkles at different face areas
Time frame: after 6 and after 12 weeks of the supplementation
Improvement of the dermis structure
Time frame: after 6 and after 12 weeks of the supplementation
An increase of the dermis thickness
Time frame: after 6 and 12 weeks of the supplementation
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 8 Oct 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.
Janko Zmitek, PhD study chair
VIST - Faculty of Applied Sciences
Katja Zmitek, PhD study director
VIST - Faculty of Applied Sciences
Liljana Mervic, PhD study chair
UL MF
Questions about this trial
What is this clinical trial studying?
A study testing Quvital LD group and Quvital HD group in people with Wrinkles and Ageing, run by VIST - Faculty of Applied Sciences.
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 4 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 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Improvement of photoprotective function of the skin (time frame: after 12 weeks of the supplementation). 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 8 Oct 2021.