Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers

Study Overview
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Brief Summary
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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

Official Title
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A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot Trial in Healthy, Young Female Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Seresis®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seresis®<br>2 capsules per day for a period of 16 consecutive weeks | Drug: Seresis®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total antioxidant capacity in skin biopsies |  | Day 0, Day 112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Plasma levels of vitamin C and E and carotenoids |  | Day 0, 14, 28, 42, 56, 84, 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 | 
| Assessment of tolerability by investigator on a 4-point scale |  | Day 112 | 
| Assessment of tolerability by volunteers on a 4-point scale |  | Day 112 | 
| Number of patients with abnormal changes in laboratory parameters |  | up to 112 days |