Status:
COMPLETED
Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
FEMALE
18-30 years
Phase:
PHASE2
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02191813
Start Date
March 1 2000
Last Update
July 17 2014
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