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

NCT02191813 | Completed Phase 2

• 1 other identifier: 1135.3
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• 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

Study Arms (2)

Seresis®

EXPERIMENTAL

Drug: Seresis®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Seresis® DRUG

Seresis®

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2014
• First Posted: July 16, 2014
• Study Start: March 1, 2000
• Primary Completion: July 1, 2000
• Last Updated: July 17, 2014

Record last verified: 2014-07