Pilot Study to Assess Number of Patients for Main Trial
Primary Purpose
Wound Healing
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing
Eligibility Criteria
Inclusion Criteria:
- Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
Exclusion Criteria:
- 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
- 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dexpanthenol
Placebo
Arm Description
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
Subjects received applications of placebo corresponding to verum
Outcomes
Primary Outcome Measures
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%
Secondary Outcome Measures
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
Number of participants with adverse events
Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02734628
Brief Title
Pilot Study to Assess Number of Patients for Main Trial
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexpanthenol
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received applications of placebo corresponding to verum
Intervention Type
Drug
Intervention Name(s)
Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
Intervention Description
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to Bepanthen® ointment without active ingredient dexpanthenol
Primary Outcome Measure Information:
Title
Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
Description
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%
Time Frame
At Day 5
Secondary Outcome Measure Information:
Title
Subjective assessment of cosmetic outcome
Description
It was assessed by using a visual analog scale (VAS) ranging from 0 being poor, 5 being moderate to 10 being excellent
Time Frame
At Days 15 and 36
Title
Number of participants with adverse events
Time Frame
Approximately 5 weeks per subject
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
Exclusion Criteria:
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
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Hamburg
ZIP/Postal Code
22869
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
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Pilot Study to Assess Number of Patients for Main Trial
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