Pilot Study to Assess Number of Patients for Main Trial

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Pantothenic Acid

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)