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

NCT ID: NCT02191852

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-06-30

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seresis®

2 capsules per day for a period of 16 consecutive weeks

Group Type: EXPERIMENTAL

Seresis®

Intervention Type: DRUG

Interventions

Seresis®

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1135.4

Identifier Type: -

Identifier Source: org_study_id