Skip to main content
OpenTrials
Completed

NCT Number: NCT02604641

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Group

Dietary Supplement

Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.

Quvital LD group

Dietary Supplement

Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.

Quvital HD group

Dietary Supplement

Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

VIST - Faculty of Applied Sciences

Other

Collaborators

  • Institute of Nutrition, Slovenia (Nutris)
  • Valens Int. d.o.o., Slovenija

Registry information

Official study title

Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2015
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.