HealthyPhase 1NCT00885937
Comparative Safety Study of New Sinecort Formulation Versus Positive Control
A Phase 1 study testing Dexpanthenol (Sinecort, BAY81-2996) and Untreated skin under application chamber in people with Healthy, run by Bayer at 1 site in Germany.
Trial summary
The study is focused to prove a favorable safety profile of the new formulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexpanthenol (Sinecort, BAY81-2996) and Untreated skin under application chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to May 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of at least 18 years
- Skin type I, II, or III according to Fitzpatrick
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Who cannot join
- Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
- Known skin allergies.
- Dermatologic diseases that might interfere with the evaluation of test site reaction.
- Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
- Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
- Within 3 weeks prior to Day 1 and during the entire trial. Any systemic or topical medication likely to interfere with the trial purposes: e.g. immune-modulating therapy (e.g. corticosteroids, cytotoxics or immunosuppressants) and any dermatological medication (drug or medical device.
- Within 1 week prior to Day 1 and during the entire trial any medication with common effects on the perfusion of skin vessels (e.g. vasodilators or vasoconstrictors, ß-receptor blocking drugs, antihistamines) should not be used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-blind, Randomized, Controlled, Single Center Trial to Evaluate the Skin Irritation Potential of a New Topical Formulation by Means of an Occlusive Patch Test in Healthy Subjects.
The study is focused to prove a favorable safety profile of the new formulation.
- Conditions
- Healthy
- Being tested
- Dexpanthenol (Sinecort, BAY81-2996), Positive control, Na-laurylsulfat-solution, Untreated skin under application chamber
- Keywords
- Dexpanthenol, Safety,, New formulation, Topical administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexpanthenol (Sinecort, BAY81-2996)Drug
1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter)
Positive control, Na-laurylsulfat-solutionDrug
50 mikro liter of 0.5 % Sodium-laurylsulfate-solution
Untreated skin under application chamberDevice
Application of treatment chamber as in arm 1 and arm 2 on untreated skin
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Dexpanthenol (Sinecort, BAY81-2996) |
| Arm 2 | Active comparator | Not described Receives: Drug: Positive control, Na-laurylsulfat-solution |
| Arm 3 | Placebo comparator | Not described Receives: Device: Untreated skin under application chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation rate
Measured: After 21 applications
Secondary outcomes (1)
Irritation potential
Measured: After 21 applications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionMay 2009
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 BayerThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885937
- Sponsor's protocol ID
- 13941
- Other IDs
- 2008-008138-36, Sinecort, 2008
- Status last verified
- Jun 2014
- First submitted
- 21 Apr 2009
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-blind, Randomized, Controlled, Single Center Trial to Evaluate the Skin Irritation Potential of a New Topical Formulation by Means of an Occlusive Patch Test in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00885937
- Acronym / sponsor ID
- 13941
- Conditions
- Healthy
- Keywords
- Dexpanthenol, Safety,, New formulation, Topical administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Apr 2009 (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.
The study is focused to prove a favorable safety profile of the new formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dexpanthenol (Sinecort, BAY81-2996) |
| Arm 2 | Active comparator | Drug: Positive control, Na-laurylsulfat-solution |
| Arm 3 | Placebo comparator | Device: Untreated skin under application chamber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of at least 18 years
- Skin type I, II, or III according to Fitzpatrick
- Subjects of childbearing potential must use an acceptable method of contraception. Hormonal or oral contraceptive drugs, intra-uterine devices (IUD) and abstinence are considered acceptable methods of contraception.
Key exclusion criteria (7 listed)
- Clinical history suggestive of intolerance, allergies or idiosyncrasies to one of the products or the ingredients of the products including the patch.
- Known skin allergies.
- Dermatologic diseases that might interfere with the evaluation of test site reaction.
- Other(s), considered as important by the investigator (e.g. multiple birth marks in the test area, important hair growth in the test area, pigmented or extremely suntanned skin impairing visual assessment, tattoos in the test area.
- Topical use of any cosmetic preparation on the test areas within 5 days prior to Day 1 (Start of Treatment) or during the trial
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 |
|---|---|---|
| Dexpanthenol (Sinecort, BAY81-2996)1 squeeze of Sinecort cream sufficient to cover the area of the application chamber, (=50 mikro liter) | Drug | Arm 1 |
| Positive control, Na-laurylsulfat-solution50 mikro liter of 0.5 % Sodium-laurylsulfate-solution | Drug | Arm 2 |
| Untreated skin under application chamberApplication of treatment chamber as in arm 1 and arm 2 on untreated skin | Device | Arm 3 |
Primary outcome
Irritation rate
Time frame: After 21 applications
1 secondary outcome
Irritation potential
Time frame: After 21 applications
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 23 Jun 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.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexpanthenol (Sinecort, BAY81-2996) and Untreated skin under application chamber in people with Healthy, run by Bayer at 1 site in Germany.
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 3 inclusion and 7 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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?
Irritation rate (time frame: After 21 applications). 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 23 Jun 2014.