Study 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

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

March 2007 - April 2007

Phase

Phase 4

Could I Receive a placebo

Yes

Products

Dexpanthenol (BAY81-2996)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	proDerm	Hamburg, 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%
Time Frame:
At Day 5
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
Time Frame:
At Days 15 and 36
Safety Issue:
No
Number of participants with adverse events
Time Frame:
Approximately 5 weeks per subject
Safety Issue:
Yes
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
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

Additional Information

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