NCT02191813CompletedPhase 2
The Ability of Seresis to Act as a Skin Protection Agent: a Double-blind, Parallel Group, Placebo-controlled Trial in Healthy, Young Female Volunteers
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 48
- Primary Endpoint
- Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Seresis®
Experimental
Intervention: Seresis® (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
Time Frame: Day 84
Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples
Time Frame: Day 84
Secondary Outcomes
- 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)
Investigators
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