Wound HealingPhase 4NCT02734628
Pilot Study to Assess Number of Patients for Main Trial
A Phase 4 study testing Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) in people with Wound Healing, run by Bayer at 1 site in Germany.
Trial summary
The objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2007to Apr 2007
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
Who cannot join
- Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
- History of keloids and hypertrophic scars
- History of plaster sensitivity
- Intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study
- Concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study
- Any condition or treatment which might influence the study
Show all 16Show fewer
- Change of hormonal contraception within 3 months prior to enrolment and during the study
- Application of any topical treatment at the test areas during the conduct of the study
- Intensive ultraviolet-light exposure within two weeks before the beginning as well as during the study
- Removal of axillary lymph nodes
- Allergy to the ingredients of the test product
- Pregnancy or lactation
- Any illness on account of which the subject should not participate in the study in the opinion of the investigator
- Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing
- Any history of drug addiction or alcoholism in the past 3 years
- Infectious diseases (e.g. hepatitis or AIDS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single Center, Intra-individual Comparison Study With Repeated Application to Assess the Wound-healing Efficacy of a 5% Dexpanthenol Ointment Compared With Placebo in Patients With Superficial, Abrasive Wounds
The objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5.
The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36 (investigator and subject), and documentation and analysis of safety parameters.
- Conditions
- Wound Healing
- Being tested
- Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)Drug
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
PlaceboDrug
Placebo to Bepanthen® ointment without active ingredient dexpanthenol
| Study group | Role | What they receive |
|---|---|---|
| Dexpanthenol | Experimental | A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions Receives: Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) |
| Placebo | Placebo comparator | Subjects received applications of placebo corresponding to verum Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
Wound healing effect (=re-epithelization) was determined on the following basis:
No healing 0% Re-epithelization >0 up to 25% Re-epithelization >25 up to 50% Re-epithelization >50 up to 75% Re-epithelization >75 but not complete Complete closure of surface 100%
Measured: At Day 5
Secondary outcomes (3)
Subjective assessment of cosmetic outcome
It was assessed by using a visual analog scale (VAS) ranging from 0 being poor, 5 being moderate to 10 being excellent
Measured: At Days 15 and 36
Number of participants with adverse events
Measured: Approximately 5 weeks per subject
Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
Measured: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2007
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 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
- NCT02734628
- Sponsor's protocol ID
- 12631
- Other IDs
- 2006-005508-14
- Status last verified
- Apr 2016
- First submitted
- 7 Apr 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Center, Intra-individual Comparison Study With Repeated Application to Assess the Wound-healing Efficacy of a 5% Dexpanthenol Ointment Compared With Placebo in Patients With Superficial, Abrasive Wounds
- ClinicalTrials.gov ID
- NCT02734628
- Acronym / sponsor ID
- 12631
- Conditions
- Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Apr 2016 (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 objective of the study was to investigate the efficacy of Bepanthen® wound healing ointment compared to placebo in a superficial abrasive wound model. The primary objective was the re-epithelization at Day 5.
The secondary objectives were re-epithelization at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15, assessment of cosmetic outcome/acceptance at Day 15 (investigator only) and at Day 36 (investigator and subject), and documentation and analysis of safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexpanthenol | Experimental | Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received applications of placebo corresponding to verum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
Key exclusion criteria (16 listed)
- Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
- History of keloids and hypertrophic scars
- History of plaster sensitivity
- Intake of drugs interfering with the immune system within 30 days before day 1 as well as during the study
- Concomitant therapy with substances affecting blood coagulation within up to 14 days prior to the start of the study as well as during the study
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 (Bepanthen® Wund- und Heilsalbe, BAY81-2996)30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment | Drug | Dexpanthenol |
| PlaceboPlacebo to Bepanthen® ointment without active ingredient dexpanthenol | Drug | Placebo |
Primary outcome
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
Time frame: At Day 5
Wound healing effect (=re-epithelization) was determined on the following basis: No healing 0% Re-epithelization >0 up to 25% Re-epithelization >25 up to 50% Re-epithelization >50 up to 75% Re-epithelization >75 but not complete Complete closure of surface 100%
3 secondary outcomes
Subjective assessment of cosmetic outcome
Time frame: At Days 15 and 36
Number of participants with adverse events
Time frame: Approximately 5 weeks per subject
Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
Time frame: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
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 12 Apr 2016.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link 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.
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 4 study testing Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) in people with Wound Healing, 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 1 inclusion and 16 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 12 Apr 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo (time frame: At Day 5). 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 12 Apr 2016.