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Completed

NCT Number: NCT00363038

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

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.

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Key information

Conditions

Ecchymosis Blood Coagulation Disorders Contusions Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Wounds and Injuries Wounds, Nonpenetrating

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Petrolatum United States Pharmacopeia (USP)

Drug

Topical formation applied to bruise twice daily for 2 weeks.

Vitamin K and retinol ointment

Drug

Topical formation applied to bruise twice daily for 2 weeks.

Arnica ointment

Drug

Topical formation applied to bruise twice daily for 2 weeks.

Vitamin K ointment

Drug

Topical formation applied to bruise twice daily for 2 weeks.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Aug 15, 2006
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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