Clinical trial NCT02191813: Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
timeFrame: Day 84
measure: Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples
timeFrame: Day 84
Secondary outcomes:
measure: Changes in MMP-1 levels measured in skin samples
timeFrame: up to day 84
measure: Changes in MMP-9 levels measured in skin samples
timeFrame: up to day 84
measure: Changes in MMP-3 levels measured in skin samples
timeFrame: up to day 84
measure: Changes in pro-MMPs levels measured in skin samples
timeFrame: up to day 84
measure: Changes in tissue inhibitor (TIMP-1) levels measured in skin samples
timeFrame: up to day 84
measure: Heme oxygenase-1 level measured in skin samples
timeFrame: up to day 84
measure: Density of Langerhans cells measured in skin samples
timeFrame: up to day 84
measure: Cell proliferation and differentiation measured in skin samples
timeFrame: up to day 84
measure: Plasma levels of vitamin E
timeFrame: up to day 84
measure: Plasma levels of beta-carotene
timeFrame: up to day 84
measure: Number of subjects with adverse events
timeFrame: up to 112 days
measure: Number of subjects with abnormal changes in laboratory parameters
timeFrame: up to day 98
measure: Assessment of tolerability by investigator on a 4-point scale
timeFrame: Day 84
measure: Assessment of tolerability by volunteer on a 4-point scale
timeFrame: Day 84
measure: Recall antigene (skin immune status) measured in the skin sample
timeFrame: up to 84 days
measure: Assessment of light sensitivity
timeFrame: up to 84 days
Other outcomes:
Locations:
Study officials:
References: