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

NCT02191852 | Completed Phase 1

• 1 other identifier: 1135.4
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Total antioxidant capacity in skin biopsies

  Day 0, Day 112

Secondary Outcomes (10)

• 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

Study Arms (1)

Seresis®

EXPERIMENTAL

2 capsules per day for a period of 16 consecutive weeks

Drug: Seresis®

Interventions

Seresis® DRUG

Seresis®

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: June 1, 1999
• Primary Completion: October 1, 1999
• Last Updated: July 17, 2014

Record last verified: 2014-07