Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries

Bayer

Status and phase: Completed; Phase 4

Conditions: Cell Proliferation; Wound Healing; Gene Expression

Treatments: Drug: Dexpanthenol (BAY81-2996); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00859196

13069

2008-002069-30 (EudraCT Number)

Details and patient eligibility

About

In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a role during cell proliferating processes.The aim of this study is to investigate the molecular effect of Dexpanthenol on human living skin, during wound healing.

Enrollment: 15 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Skin type I to IV
• Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches

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
• Frequent visits of tanning booths
• Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Dexpanthenol (BAY81-2996)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo