HealthyPhase 2NCT02191813
Study to Determine the Ability of Seresis to Act as a Skin Protection Agent in Healthy Young Female Volunteers
A Phase 2 study testing Seresis® in people with Healthy, run by Boehringer Ingelheim.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Seresis®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2000to Jul 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
About this study
Official 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
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
- Being tested
- Seresis®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seresis®Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Seresis® | Experimental | Not described Receives: Drug: Seresis® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples
Measured: Day 84
Absolute changes in MMP-9 levels (activity and protein expression) measured in skin samples
Measured: Day 84
Secondary outcomes (16)
Changes in MMP-1 levels measured in skin samples
Measured: up to day 84
Changes in MMP-9 levels measured in skin samples
Measured: up to day 84
Changes in MMP-3 levels measured in skin samples
Measured: up to day 84
Changes in pro-MMPs levels measured in skin samples
Measured: up to day 84
Changes in tissue inhibitor (TIMP-1) levels measured in skin samples
Measured: up to day 84
Heme oxygenase-1 level measured in skin samples
Measured: up to day 84
Density of Langerhans cells measured in skin samples
Measured: up to day 84
Cell proliferation and differentiation measured in skin samples
Measured: up to day 84
Plasma levels of vitamin E
Measured: up to day 84
Plasma levels of beta-carotene
Measured: up to day 84
Number of subjects with adverse events
Measured: up to 112 days
Number of subjects with abnormal changes in laboratory parameters
Measured: up to day 98
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 84
Assessment of tolerability by volunteer on a 4-point scale
Measured: Day 84
Recall antigene (skin immune status) measured in the skin sample
Measured: up to 84 days
Assessment of light sensitivity
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startMar 2000
- Primary completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191813
- Sponsor's protocol ID
- 1135.3
- Status last verified
- Jul 2014
- First submitted
- 14 Jul 2014
- Last updated
- 17 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02191813
- Acronym / sponsor ID
- 1135.3
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Jul 2000 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seresis® | Experimental | Drug: Seresis® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seresis® | Drug | Seresis® |
| Placebo | Drug | Placebo |
Primary outcome
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
16 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seresis® in people with Healthy, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute changes in MMP-1 levels (activity and protein expression) measured in skin samples (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.