ErythemaPhase 2NCT00839462
Efficacy of Dexpanthenol in Thermic Erythema
A Phase 2 study testing Dexpanthenol foam spray, new formulation and Dexpanthenol foam spray, old formulation in people with Erythema, run by Bayer at 1 site in France.
Trial summary
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erythema
- What is being tested?
- Dexpanthenol foam spray, new formulation and Dexpanthenol foam spray, old formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Sep 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Phototype: I to IV according to Fitzpatrick scale
Who cannot join
- Pregnant or nursing women
- Subjects registered as being in exclusion period in the French Health Minister file of subjects
- Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.
The study focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.
- Conditions
- Erythema
- Being tested
- Dexpanthenol foam spray, new formulation, Dexpanthenol foam spray, old formulation
- Keywords
- Thermal Erythema, Dexpanthenol, Erythema, Efficacy
- Medical subject headings
- Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexpanthenol foam spray, new formulationDrug
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
Dexpanthenol foam spray, old formulationDrug
2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Dexpanthenol foam spray, new formulation |
| Arm 2 | Active comparator | Not described Receives: Drug: Dexpanthenol foam spray, old formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
Measured: 2 min, 5 min, 10 min, 15 min
Secondary outcomes (4)
Skin temperature
Measured: 2 min, 5 min, 10 min
Evaluation of the cooling/soothing effect (scores) after first and second application
Measured: 2 min, 5min, 10 min, 15 min
Evaluation of the foam covering properties after first application
Measured: 2 min, 5 min, 10 min, 15 min
Incidence of adverse events
Measured: FPFV - LPLV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startSep 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ErythemaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 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
- NCT00839462
- Sponsor's protocol ID
- 12039
- Status last verified
- Oct 2013
- First submitted
- 6 Feb 2009
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Bepanthen Burn Relief Foam Spray New Formula on a Thermic Erythema. Equivalence Trial. Intra-individual Design.
- ClinicalTrials.gov ID
- NCT00839462
- Acronym / sponsor ID
- 12039
- Conditions
- Erythema
- Keywords
- Thermal Erythema, Dexpanthenol, Erythema, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 9 Feb 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 focuses to prove the equivalent efficacy of two different Dexpanthenol formulations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Dexpanthenol foam spray, new formulation |
| Arm 2 | Active comparator | Drug: Dexpanthenol foam spray, old formulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects
- Phototype: I to IV according to Fitzpatrick scale
Key exclusion criteria (3 listed)
- Pregnant or nursing women
- Subjects registered as being in exclusion period in the French Health Minister file of subjects
- Subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested
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 foam spray, new formulation2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter | Drug | Arm 1 |
| Dexpanthenol foam spray, old formulation2 applications of 2 micro liter/square centimeter on a 4X4 cm area corresponding to 32 micro liter | Drug | Arm 2 |
Primary outcome
Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application
Time frame: 2 min, 5 min, 10 min, 15 min
4 secondary outcomes
Skin temperature
Time frame: 2 min, 5 min, 10 min
Evaluation of the cooling/soothing effect (scores) after first and second application
Time frame: 2 min, 5min, 10 min, 15 min
Evaluation of the foam covering properties after first application
Time frame: 2 min, 5 min, 10 min, 15 min
Incidence of adverse events
Time frame: FPFV - LPLV
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 21 Oct 2013.
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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 2 study testing Dexpanthenol foam spray, new formulation and Dexpanthenol foam spray, old formulation in people with Erythema, run by Bayer at 1 site in France.
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 2 inclusion and 3 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 21 Oct 2013. 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 France. 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. 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?
Global sum of scores for evaluating the cooling/soothing effect evaluated after first and second application (time frame: 2 min, 5 min, 10 min, 15 min). 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 21 Oct 2013.