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Completed

NCT Number: NCT02191852

Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers

Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female volunteers between 18 and 30 years
  • With skin type II or skin type III
  • BMI < 25
  • Non-smokers
  • Volunteers who have given their written informed consent according to Good Clinical Practice (GCP) and local regulations

Exclusion criteria

  • Any serious disorder that may interfere with her participation to the trial and evaluation of the safety of the test drug (e.g. liver and/or renal disease, hypervitaminosis A, psychic disorder, etc.), and/or treatment with chronic medication
  • Pre-treatment (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology and may interfere with evaluation of the safety of the test drug (e.g. vitamins and minerals supplementation)
  • Relevant allergy or known hypersensitivity to the investigational drug or its excipients
  • High performance sports
  • Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (DSM-IV)
  • Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine devices (IUDs), sterilisation)
  • Pregnancy and/or lactation
  • Known abnormal values of the lab tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)
  • Abnormal values of low density lipoproteins (LDL) and triglycerides (TGL) levels in blood
  • Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
  • Specific dietary requirements that do not allow the volunteers to meet the dietary guidelines set out for this study

Treatment and study plan

Seresis®

Drug

Primary outcomes

  1. Total antioxidant capacity in skin biopsies

    Time frame: Day 0, Day 112

Secondary outcomes

  1. Total antioxidant capacity in skin biopsies

    Time frame: Day 0, Day 56

  2. Total antioxidant capacity in buccal mucosa cells (BMCs)

    Time frame: Day 0, 14, 28, 42, 56, 84, 112

  3. Total antioxidant capacity in plasma

    Time frame: Day 0, 14, 28, 42, 56, 84, 112

  4. Plasma levels of vitamin C and E and carotenoids

    Time frame: Day 0, 14, 28, 42, 56, 84, 112

  5. Levels of vitamin E and carotenoids in skin biopsies

    Time frame: Day 0, 56, 112

  6. Levels of vitamin E and carotenoids in BMCs

    Time frame: Day 0, 14, 28, 42, 56, 84, 112

  7. Number of subjects with adverse events

    Time frame: up to 119 days

  8. Assessment of tolerability by investigator on a 4-point scale

    Time frame: Day 112

  9. Assessment of tolerability by volunteers on a 4-point scale

    Time frame: Day 112

  10. Number of patients with abnormal changes in laboratory parameters

    Time frame: up to 112 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot Trial in Healthy, Young Female Volunteers

Important dates

Study start
1999
Primary completion
1999
First posted
Jul 16, 2014
Registry last updated
Jul 17, 2014

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.

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