Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers
Phase 2
Completed
- Conditions
- Healthy
- Interventions
- Drug: Seresis®Drug: Placebo
- Registration Number
- NCT02191813
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 48
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seresis® Seresis® - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples Day 84 Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples Day 84
- Secondary Outcome Measures
Name Time Method Plasma levels of beta-carotene up to day 84 Number of subjects with adverse events up to 112 days Number of subjects with abnormal changes in laboratory parameters up to day 98 Assessment of tolerability by investigator on a 4-point scale Day 84 Assessment of tolerability by volunteer on a 4-point scale Day 84 Recall antigene (skin immune status) measured in the skin sample up to 84 days Assessment of light sensitivity up to 84 days Changes in MMP-1 levels measured in skin samples up to day 84 Changes in MMP-9 levels measured in skin samples up to day 84 Changes in MMP-3 levels measured in skin samples up to day 84 Changes in pro-MMPs levels measured in skin samples up to day 84 Changes in tissue inhibitor (TIMP-1) levels measured in skin samples up to day 84 Heme oxygenase-1 level measured in skin samples up to day 84 Density of Langerhans cells measured in skin samples up to day 84 Cell proliferation and differentiation measured in skin samples up to day 84 Plasma levels of vitamin E up to day 84