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Completed

NCT Number: NCT02734628

Pilot Study to Assess Number of Patients for Main Trial

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.

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Key information

Conditions

Wound Healing

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamburg, Free and Hanseatic City of Hamburg, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)

Drug

30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment

Placebo

Drug

Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Primary outcomes

  1. 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%

Secondary outcomes

  1. Subjective assessment of cosmetic outcome

    Time frame: 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

  2. Number of participants with adverse events

    Time frame: Approximately 5 weeks per subject

  3. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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