check_circleStudy Completed

Wound Healing

Bayer Identifier:

12631

ClinicalTrials.gov Identifier:

NCT02734628

EudraCT Number:

2006-005508-14

EU CT Number:

Not Available
Pilot study to assess number of patients for main trial

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.

Key Participants Requirements

Sex

Both

Age

18 - 45 Years
  • - Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV
  • - 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
28
Trial Dates
March 2007 - April 2007
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Dexpanthenol (BAY81-2996)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
proDermHamburg, 22869, Germany

Primary Outcome

  • 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%
    date_rangeTime Frame:
    At Day 5
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    At Days 15 and 36
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 5 weeks per subject
    enhanced_encryption
    Safety Issue:
    Yes
  • Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
    date_rangeTime Frame:
    At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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