Pharmacokinetic Study of Seresis® in the Skin in Healthy... | NCT02191852

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

NCT02191852

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 17, 2014Estimated

Enrollment

8Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Seresis®

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1999

Primary Completion Date

Oct 1999Actual

Completion Date

Not provided

First Submitted Date

Jul 14, 2014

First Submission Date that Met QC Criteria

Jul 14, 2014

First Posted Date

Jul 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2014

Last Update Posted Date

Jul 17, 2014Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Label	Type	Description	Intervention Names
Seresis®	Experimental	2 capsules per day for a period of 16 consecutive weeks	Drug: Seresis®

Name	Type	Description	Arm Group Labels	Other Names
Seresis®	Drug		Seresis®

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided