Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00363038
First received: August 10, 2006
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.


Condition Intervention
Ecchymosis
Drug: Petrolatum United States Pharmacopeia (USP)
Drug: Vitamin K and retinol ointment
Drug: Arnica ointment
Drug: Vitamin K ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Average Bruise Change [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).


Enrollment: 16
Study Start Date: July 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Drug: Petrolatum United States Pharmacopeia (USP)
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Vitamin K and retinol ointment
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Arnica ointment
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Vitamin K ointment
Topical formation applied to bruise twice daily for 2 weeks.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 20-60
  • Subjects are in good health.
  • Subjects have willingness and the ability to understand and provide informed consent for participation in the study.

Exclusion Criteria:

  • Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
  • Subjects who have a history of bleeding disorders.
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
  • Subjects who are pregnant or nursing.
  • Subjects who have active systemic or local infection
  • Subjects with systemic or local skin disease.
  • Subjects with systemic illness.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00363038

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

Publications:
Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00363038     History of Changes
Other Study ID Numbers: 1253-015
Study First Received: August 10, 2006
Results First Received: November 29, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Northwestern University:
Bruising
Topical 20% arnica

Additional relevant MeSH terms:
Contusions
Ecchymosis
Wounds and Injuries
Wounds, Nonpenetrating
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Petrolatum
Vitamin A
Vitamin K
Vitamins
Retinol palmitate
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics

ClinicalTrials.gov processed this record on July 23, 2014