HealthyPhase 1NCT02191852
Pharmacokinetic Study of Seresis® in the Skin in Healthy Young Female Volunteers
A Phase 1 study testing Seresis® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained… 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®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Oct 1999
- Phase
- Phase 1
- 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 II or skin type III
- BMI < 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
- Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (DSM-IV)
- Female volunteers in child-bearing age not using adequate means of birth control (contraceptive pills, Intrauterine devices (IUDs), sterilisation)
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 low density lipoproteins (LDL) and triglycerides (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: A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot Trial in Healthy, Young Female Volunteers
Study to evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma
- Conditions
- Healthy
- Being tested
- Seresis®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seresis®Drug
| Study group | Role | What they receive |
|---|---|---|
| Seresis® | Experimental | 2 capsules per day for a period of 16 consecutive weeks Receives: Drug: Seresis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total antioxidant capacity in skin biopsies
Measured: Day 0, Day 112
Secondary outcomes (10)
Total antioxidant capacity in skin biopsies
Measured: Day 0, Day 56
Total antioxidant capacity in buccal mucosa cells (BMCs)
Measured: Day 0, 14, 28, 42, 56, 84, 112
Total antioxidant capacity in plasma
Measured: Day 0, 14, 28, 42, 56, 84, 112
Plasma levels of vitamin C and E and carotenoids
Measured: Day 0, 14, 28, 42, 56, 84, 112
Levels of vitamin E and carotenoids in skin biopsies
Measured: Day 0, 56, 112
Levels of vitamin E and carotenoids in BMCs
Measured: Day 0, 14, 28, 42, 56, 84, 112
Number of subjects with adverse events
Measured: up to 119 days
Assessment of tolerability by investigator on a 4-point scale
Measured: Day 112
Assessment of tolerability by volunteers on a 4-point scale
Measured: Day 112
Number of patients with abnormal changes in laboratory parameters
Measured: up to 112 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 startJun 1999
- Primary completionOct 1999
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02191852
- Sponsor's protocol ID
- 1135.4
- 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
- A Pharmacokinetic Study on the Antioxidant Activity of Seresis® in the Skin: an Open, Uncontrolled, Non-randomized Intra-individual Pilot Trial in Healthy, Young Female Volunteers
- ClinicalTrials.gov ID
- NCT02191852
- Acronym / sponsor ID
- 1135.4
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Oct 1999 (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 evaluate the total antioxidant capacity of Seresis® (with Thiobarbituric acid reactive substances (TBARS) assays)) in the skin; as well as in buccal mucosa cells (BMCs) and in plasma, compared to baseline values; furthermore to detect the quantitative enrichment of individual antioxidant compounds contained in the product and to investigate whether or not some of them accumulate in target tissues such as skin, BMCs and plasma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seresis® | Experimental | Drug: Seresis®2 capsules per day for a period of 16 consecutive weeks |
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 II or skin type III
- BMI < 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
- Alcohol and drug abuse according to Diagnostic and Statistics Manual, Version IV (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® |
Primary outcome
Total antioxidant capacity in skin biopsies
Time frame: Day 0, Day 112
10 secondary outcomes
Total antioxidant capacity in skin biopsies
Time frame: Day 0, Day 56
Total antioxidant capacity in buccal mucosa cells (BMCs)
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Total antioxidant capacity in plasma
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Plasma levels of vitamin C and E and carotenoids
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Levels of vitamin E and carotenoids in skin biopsies
Time frame: Day 0, 56, 112
Levels of vitamin E and carotenoids in BMCs
Time frame: Day 0, 14, 28, 42, 56, 84, 112
Number of subjects with adverse events
Time frame: up to 119 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Day 112
Assessment of tolerability by volunteers on a 4-point scale
Time frame: Day 112
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 112 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.
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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 1 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Total antioxidant capacity in skin biopsies (time frame: Day 0, Day 112). 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.