Pilot Study to Assess Number of Patients for Main Trial

Phase 4

Completed

• Conditions: Wound Healing
• Interventions: Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996); Drug: Placebo

• Registration Number: NCT02734628
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-07
• Last Update Submitted: 2016-04-07
• Study First Posted: 2016-04-12
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Healthy Caucasian subjects of both genders, 18 to 45 years of age, Fitzpatrick skin type I to IV

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexpanthenol	Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)	A squeeze of ointment, approximately 0.5 cm in length corresponding to an amount of about 0.3 g of ointment, which is equal to 15 mg dexpanthenol , twice daily (once in the morning and once in the evening) over a period of 14 days was applied topically under occluded conditions
Placebo	Placebo	Subjects received applications of placebo corresponding to verum

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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