Healthy
Conditions
Brief summary
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
Interventions
DRUGSeresis®
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total antioxidant capacity in skin biopsies | Day 0, Day 112 |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of tolerability by investigator on a 4-point scale | Day 112 |
| Total antioxidant capacity in skin biopsies | Day 0, Day 56 |
| Total antioxidant capacity in buccal mucosa cells (BMCs) | Day 0, 14, 28, 42, 56, 84, 112 |
| Total antioxidant capacity in plasma | Day 0, 14, 28, 42, 56, 84, 112 |
| Assessment of tolerability by volunteers on a 4-point scale | Day 112 |
| Levels of vitamin E and carotenoids in skin biopsies | Day 0, 56, 112 |
| Levels of vitamin E and carotenoids in BMCs | Day 0, 14, 28, 42, 56, 84, 112 |
| Number of subjects with adverse events | up to 119 days |
| Number of patients with abnormal changes in laboratory parameters | up to 112 days |
| Plasma levels of vitamin C and E and carotenoids | Day 0, 14, 28, 42, 56, 84, 112 |
Outcome results
None listed