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

NCT ID: NCT02191813

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Seresis®

Group Type: EXPERIMENTAL

Seresis®

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Seresis®

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1135.3

Identifier Type: -

Identifier Source: org_study_id