NCT02604641

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

7 months

First QC Date

November 4, 2015

Last Update Submit

October 5, 2021

Conditions

WrinklesAgeingPhotoprotection

Keywords

skin rejuvenationanti-ageing effectsminimal erythema dosedermis structurephysiological skin conditionwrinklingdry skin

Outcome Measures

Primary Outcomes (1)

  • 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.

    after 12 weeks of the supplementation

Secondary Outcomes (5)

  • Reduction of the area of the periorbital facial wrinkles

    after 6 and after 12 weeks of the supplementation

  • Reduction of the volume of the periorbital facial wrinkles

    after 6 and after 12 weeks of the supplementation

  • Reduction of wrinkles at different face areas

    after 6 and after 12 weeks of the supplementation

  • Improvement of the dermis structure

    after 6 and after 12 weeks of the supplementation

  • An increase of the dermis thickness

    after 6 and 12 weeks of the supplementation

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

0 mg CoQ10 daily

Dietary Supplement: Placebo group

Quvital LD group

ACTIVE COMPARATOR

50 mg CoQ10 daily

Dietary Supplement: Quvital LD group

Quvital HD group

ACTIVE COMPARATOR

150 mg CoQ10 daily

Dietary Supplement: Quvital HD group

Interventions

Placebo groupDIETARY_SUPPLEMENT

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

Placebo group
Quvital LD groupDIETARY_SUPPLEMENT

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

Quvital LD group
Quvital HD groupDIETARY_SUPPLEMENT

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

Quvital HD group

Eligibility Criteria

Age45 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Janko Zmitek, PhD

    VIST - Faculty of Applied Sciences

    STUDY CHAIR

  • Katja Zmitek, PhD

    VIST - Faculty of Applied Sciences

    STUDY DIRECTOR

  • Liljana Mervic, PhD

    UL MF

    STUDY CHAIR

  • Tina Tina Pogačnik, BSc

    VIST - Faculty of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 13, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 8, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share