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

Study Overview
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Brief Summary
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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

Official Title
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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
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Healthy

Intervention / Treatment
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* Drug: Seresis®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seresis®<br> | Drug: Seresis®<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |