Clinical trial NCT02191852: Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Total antioxidant capacity in skin biopsies
timeFrame: Day 0, Day 112
Secondary outcomes:
measure: Total antioxidant capacity in skin biopsies
timeFrame: Day 0, Day 56
measure: Total antioxidant capacity in buccal mucosa cells (BMCs)
timeFrame: Day 0, 14, 28, 42, 56, 84, 112
measure: Total antioxidant capacity in plasma
timeFrame: Day 0, 14, 28, 42, 56, 84, 112
measure: Plasma levels of vitamin C and E and carotenoids
timeFrame: Day 0, 14, 28, 42, 56, 84, 112
measure: Levels of vitamin E and carotenoids in skin biopsies
timeFrame: Day 0, 56, 112
measure: Levels of vitamin E and carotenoids in BMCs
timeFrame: Day 0, 14, 28, 42, 56, 84, 112
measure: Number of subjects with adverse events
timeFrame: up to 119 days
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Day 112
measure: Assessment of tolerability by volunteers on a 4-point scale
timeFrame: Day 112
measure: Number of patients with abnormal changes in laboratory parameters
timeFrame: up to 112 days
Other outcomes:
Locations:
Study officials:
References: