Trial Condition(s):
Wound Healing
Pilot study to assess number of patients for main trial
Bayer Identifier:
12631
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations proDerm Hamburg, Germany, 22869 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Wound healing effect (=re-epithelization) at Day 5 of the test product and the placeboWound 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%Timeframe: At Day 5
Secondary Outcome
- Subjective assessment of cosmetic outcomeIt was assessed by using a visual analog scale (VAS) ranging from 0 being poor, 5 being moderate to 10 being excellentTimeframe: At Days 15 and 36
- Number of participants with adverse eventsTimeframe: Approximately 5 weeks per subject
- Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound inductionTimeframe: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
Additional Information
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