Healthy
Conditions
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
Interventions
DRUGSeresis®
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Plasma levels of beta-carotene | 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 |
| 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 |
| Cell proliferation and differentiation measured in skin samples | 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-3 levels measured in skin samples | up to day 84 |
| Plasma levels of vitamin E | up to day 84 |
Outcome results
None listed