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

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Bayer

Status and phase

Completed
Phase 4

Conditions

Cell Proliferation
Wound Healing
Gene Expression

Treatments

Drug: Placebo
Drug: Dexpanthenol (BAY81-2996)

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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