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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00363038
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : December 4, 2012
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Ecchymosis Drug: Petrolatum United States Pharmacopeia (USP) Drug: Vitamin K and retinol ointment Drug: Arnica ointment Drug: Vitamin K ointment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Study Start Date : July 2006
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Average Bruise Change [ Time Frame: Baseline and 2 weeks ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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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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): NCT00363038


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

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Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT00363038    
Other Study ID Numbers: 1253-015
First Posted: August 15, 2006    Key Record Dates
Results First Posted: December 4, 2012
Last Update Posted: December 3, 2021
Last Verified: December 2021
Keywords provided by Murad Alam, Northwestern University:
Bruising
Topical 20% arnica
Additional relevant MeSH terms:
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Ecchymosis
Contusions
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Wounds, Nonpenetrating
Wounds and Injuries
Vitamins
Vitamin K
 Vitamin A
Petrolatum
Micronutrients
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Emollients
Dermatologic Agents