NCT02734628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
Last Updated

April 12, 2016

Status Verified

April 1, 2016

Enrollment Period

1 month

First QC Date

April 7, 2016

Last Update Submit

April 7, 2016

Conditions

Wound Healing

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Subjective assessment of cosmetic outcome

    At Days 15 and 36

  • 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

Study Arms (2)

Dexpanthenol

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

Subjects received applications of placebo corresponding to verum

Drug: Placebo

Interventions

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

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

Dexpanthenol
PlaceboDRUG

Placebo to Bepanthen® ointment without active ingredient dexpanthenol

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Hamburg, Hamburg, 22869, Germany

Location

Related Links

MeSH Terms

Interventions

dexpanthenol

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 12, 2016

Study Start

March 1, 2007

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 12, 2016

Record last verified: 2016-04

Locations

DE(1)