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Pilot Study to Assess Number of Patients for Main Trial

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ClinicalTrials.gov Identifier: NCT02734628
Recruitment Status : Completed
First Posted : April 12, 2016
Last Update Posted : April 12, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

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.


Condition or disease Intervention/treatment Phase
Wound Healing Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2007
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

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Arm Intervention/treatment
Experimental: Dexpanthenol
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
Drug: Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)
30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment

Placebo Comparator: Placebo
Subjects received applications of placebo corresponding to verum
Drug: Placebo
Placebo to Bepanthen® ointment without active ingredient dexpanthenol




Primary Outcome Measures :
  1. Wound healing effect (=re-epithelization) at Day 5 of the test product and the placebo [ Time Frame: At Day 5 ]

    Wound healing effect (=re-epithelization) was determined on the following basis:

    No healing 0% Re-epithelization >0 up to 25% Re-epithelization >25 up to 50% Re-epithelization >50 up to 75% Re-epithelization >75 but not complete Complete closure of surface 100%



Secondary Outcome Measures :
  1. Subjective assessment of cosmetic outcome [ Time Frame: At Days 15 and 36 ]
    It was assessed by using a visual analog scale (VAS) ranging from 0 being poor, 5 being moderate to 10 being excellent

  2. Number of participants with adverse events [ Time Frame: Approximately 5 weeks per subject ]
  3. Wound healing at Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 after wound induction [ Time Frame: At Days 2, 3, 4, 6, 7, 8, 9, 10 and 15 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734628


Locations
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Germany
Hamburg, Germany, 22869
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02734628     History of Changes
Other Study ID Numbers: 12631
2006-005508-14 ( EudraCT Number )
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Pantothenic Acid
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs