Pilot Study to Assess Number of Patients for Main Trial

Wound Healing Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734628
• Other study ID #: 12631
• Secondary ID: 2006-005508-14
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2016
• Last updated: April 7, 2016
• Start date: March 2007
• Est. completion date: April 2007

Study information

• Verified date: April 2016
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound Healing

Intervention

Drug:
• Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
• Placebo
Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%	At Day 5	No
Secondary	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	At Days 15 and 36	No
Secondary	Number of participants with adverse events		Approximately 5 weeks per subject	Yes
Secondary	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	No

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