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Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin

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ClinicalTrials.gov Identifier: NCT02604641
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborators:
Valens Int. d.o.o., Slovenija
Nutrition Institute, Slovenia
Information provided by (Responsible Party):
Higher School of Applied Sciences (VIST)

Brief 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 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.

Condition or disease Intervention/treatment Phase
Wrinkles Ageing Photoprotection Dietary Supplement: Placebo group Dietary Supplement: Quvital LD group Dietary Supplement: Quvital HD group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo group
0 mg CoQ10 daily
Dietary Supplement: Placebo group
Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.

Active Comparator: Quvital LD group
50 mg CoQ10 daily
Dietary Supplement: Quvital LD group
Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.

Active Comparator: Quvital HD group
150 mg CoQ10 daily
Dietary Supplement: Quvital HD group
Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reduction of the area of the periorbital facial wrinkles [ Time Frame: after 6 and after 12 weeks of the supplementation ]
    Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  2. Reduction of the volume of the periorbital facial wrinkles [ Time Frame: after 6 and after 12 weeks of the supplementation ]
    Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  3. Reduction of wrinkles at different face areas [ Time Frame: after 6 and after 12 weeks of the supplementation ]
    Expert assessment of wrinkles at different face areas (periorbital, frontal, glabelar, nasolabial areas etc.) will be done according to Lemperle Wrinkle assessment scale.

  4. Improvement of the dermis structure [ Time Frame: after 6 and after 12 weeks of the supplementation ]
    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.

  5. An increase of the dermis thickness [ Time Frame: after 6 and 12 weeks of the supplementation ]
    Dermis thickness will be measured with ultrasound imaging of the skin.



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signs of skin aging (mimic wrinkles/ poor skin tone/ visual dryness),
  • Photoaged skin on the face,
  • Expression of mimic wrinkles,
  • Phototype II and III.

Exclusion Criteria:

  • 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,
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604641


Sponsors and Collaborators
Higher School of Applied Sciences (VIST)
Valens Int. d.o.o., Slovenija
Nutrition Institute, Slovenia
Investigators
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Study Chair: Janko Zmitek, PhD Higher School of Applied Sciences (VIST)
Study Director: Katja Zmitek, PhD Higher School of Applied Sciences (VIST)
Study Chair: Liljana Mervic, PhD UL MF
Principal Investigator: Tina Tina Pogačnik, BSc Higher School of Applied Sciences (VIST)

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Responsible Party: Higher School of Applied Sciences (VIST)
ClinicalTrials.gov Identifier: NCT02604641     History of Changes
Other Study ID Numbers: Q10 01-2014
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: November 2015

Keywords provided by Higher School of Applied Sciences (VIST):
skin rejuvenation
anti-ageing effects
minimal erythema dose
dermis structure
physiological skin condition
wrinkling
dry skin

Additional relevant MeSH terms:
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Ubiquinone
Coenzyme Q10
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamins