Wound Healing
Conditions
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.
Interventions
DRUGDexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
DRUGPlacebo
Placebo to Bepanthen® ointment without active ingredient dexpanthenol
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective assessment of cosmetic outcome | At Days 15 and 36 | 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 | Approximately 5 weeks per subject | — |
| Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction | At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 | — |
Countries
Germany
Outcome results
None listed