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Pilot Study to Assess Number of Patients for Main Trial

Primary Purpose

Wound Healing

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexpanthenol

Placebo

Arm Description

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

Subjects received applications of placebo corresponding to verum

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

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

Number of participants with adverse events

Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction

Full Information

NCT ID

NCT02734628

First Posted

April 7, 2016

Last Updated

April 7, 2016

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02734628

Brief Title

Pilot Study to Assess Number of Patients for Main 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexpanthenol

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects received applications of placebo corresponding to verum

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Primary Outcome Measure Information:

Title

Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo

Description

Time Frame

At Day 5

Secondary Outcome Measure Information:

Title

Subjective assessment of cosmetic outcome

Description

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

Title

Number of participants with adverse events

Time Frame

Approximately 5 weeks per subject

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Hamburg

ZIP/Postal Code

22869

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

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Pilot Study to Assess Number of Patients for Main Trial

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