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

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 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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Seresis®

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seresis®; 2 capsules per day for a period of 16 consecutive weeks	Drug: Seresis®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 1999
• Primary Completion (Actual): October 1, 1999

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: July 16, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1135.4