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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Healthy

Treatments

Drug: Seresis®

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02191813

1135.3

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

Female

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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