NCT Number: NCT02191813
Study to Determine the Ability of Seresis to Act as a Skin Protection Agent 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
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Notify MeKey information
Conditions
Age range
18 year–30 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugPrimary 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
Time frame: up to day 84
-
Changes in MMP-9 levels measured in skin samples
Time frame: up to day 84
-
Changes in MMP-3 levels measured in skin samples
Time frame: up to day 84
-
Changes in pro-MMPs levels measured in skin samples
Time frame: up to day 84
-
Changes in tissue inhibitor (TIMP-1) levels measured in skin samples
Time frame: up to day 84
-
Heme oxygenase-1 level measured in skin samples
Time frame: up to day 84
-
Density of Langerhans cells measured in skin samples
Time frame: up to day 84
-
Cell proliferation and differentiation measured in skin samples
Time frame: up to day 84
-
Plasma levels of vitamin E
Time frame: up to day 84
-
Plasma levels of beta-carotene
Time frame: up to day 84
-
Number of subjects with adverse events
Time frame: up to 112 days
-
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to day 98
-
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 84
-
Assessment of tolerability by volunteer on a 4-point scale
Time frame: Day 84
-
Recall antigene (skin immune status) measured in the skin sample
Time frame: up to 84 days
-
Assessment of light sensitivity
Time frame: up to 84 days
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study 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
Important dates
- Study start
- 2000
- Primary completion
- 2000
- First posted
- Jul 16, 2014
- Registry last updated
- Jul 17, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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