Clinical trial NCT02734628: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Healing
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo
timeFrame: At Day 5
Secondary outcomes:
measure: Subjective assessment of cosmetic outcome
timeFrame: At Days 15 and 36
measure: Number of participants with adverse events
timeFrame: Approximately 5 weeks per subject
measure: Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction
timeFrame: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15
Other outcomes:
Locations:
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: