Pilot Study to Assess Number of Patients for Main Trial

Bayer

Status and phase: Completed; Phase 4

Conditions: Wound Healing

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02734628

2006-005508-14 (EudraCT Number)

12631

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

Dexpanthenol

Experimental group

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

Subjects received applications of placebo corresponding to verum

Treatment:

Drug: Placebo