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

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

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