Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers

The Ability of Seresis to Act as a Skin Protection Agent: a Double-blind, Parallel Group, Placebo-controlled Trial in Healthy, Young Female Volunteers

Study to detect the efficacy of Seresis® in reducing the damage produced on the skin by Matrix-metalloproteinases (MMP) and by oxidative stress (marker: heme oxygenase-1 expression) activated by UV radiation

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 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 I or skin type II
• Body Mass Index > 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 people
• Alcohol and drug abuse according to Diagnostic and Statistics Manual (DSM-IV)
• Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, intrauterine device (IUDs), sterilization)
• 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 Aspartate Transferase (SGOT/ASAT), Alanine Transferase (SGPT/ALAT)-, Gamma-glutamyl transpeptidase, Low density Lipoproteins/Triglycerides (LDL/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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Seresis®	Drug: Seresis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples	Day 84
Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples	Day 84

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in MMP-1 levels measured in skin samples	up to day 84
Changes in MMP-9 levels measured in skin samples	up to day 84
Changes in MMP-3 levels measured in skin samples	up to day 84
Changes in pro-MMPs levels measured in skin samples	up to day 84
Changes in tissue inhibitor (TIMP-1) levels measured in skin samples	up to day 84
Heme oxygenase-1 level measured in skin samples	up to day 84
Density of Langerhans cells measured in skin samples	up to day 84
Cell proliferation and differentiation measured in skin samples	up to day 84
Plasma levels of vitamin E	up to day 84
Plasma levels of beta-carotene	up to day 84
Number of subjects with adverse events	up to 112 days
Number of subjects with abnormal changes in laboratory parameters	up to day 98
Assessment of tolerability by investigator on a 4-point scale	Day 84
Assessment of tolerability by volunteer on a 4-point scale	Day 84
Recall antigene (skin immune status) measured in the skin sample	up to 84 days
Assessment of light sensitivity	up to 84 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2000
• Primary Completion (Actual): July 1, 2000

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: 1135.3