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OpenTrials
Completed

NCT Number: NCT02191813

Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers

Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression) activated by UV radiation

Completed

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

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 I or skin type II
  • Body Mass Index > 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 people
  • Alcohol and drug abuse according to Diagnostic and Statistics Manual (DSM-IV)
  • Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, intrauterine device (IUDs), sterilization)
  • 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 Aspartate Transferase (SGOT/ASAT), Alanine Transferase (SGPT/ALAT)-, Gamma-glutamyl transpeptidase, Low density Lipoproteins/Triglycerides (LDL/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

Placebo

Drug

Primary outcomes

  1. Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples

    Time frame: Day 84

  2. Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples

    Time frame: Day 84

Secondary outcomes

  1. Changes in MMP-1 levels measured in skin samples

    Time frame: up to day 84

  2. Changes in MMP-9 levels measured in skin samples

    Time frame: up to day 84

  3. Changes in MMP-3 levels measured in skin samples

    Time frame: up to day 84

  4. Changes in pro-MMPs levels measured in skin samples

    Time frame: up to day 84

  5. Changes in tissue inhibitor (TIMP-1) levels measured in skin samples

    Time frame: up to day 84

  6. Heme oxygenase-1 level measured in skin samples

    Time frame: up to day 84

  7. Density of Langerhans cells measured in skin samples

    Time frame: up to day 84

  8. Cell proliferation and differentiation measured in skin samples

    Time frame: up to day 84

  9. Plasma levels of vitamin E

    Time frame: up to day 84

  10. Plasma levels of beta-carotene

    Time frame: up to day 84

  11. Number of subjects with adverse events

    Time frame: up to 112 days

  12. Number of subjects with abnormal changes in laboratory parameters

    Time frame: up to day 98

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

    Time frame: Day 84

  14. Assessment of tolerability by volunteer on a 4-point scale

    Time frame: Day 84

  15. Recall antigene (skin immune status) measured in the skin sample

    Time frame: up to 84 days

  16. Assessment of light sensitivity

    Time frame: up to 84 days

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Ability of Seresis to Act as a Skin Protection Agent: a Double-blind, Parallel Group, Placebo-controlled Trial in Healthy, Young Female Volunteers

Important dates

Study start
2000
Primary completion
2000
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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