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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Northwestern University

Current Primary Outcome: 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).


Original Primary Outcome: Days to resolution of ecchymoses, as determined by patient report and two double-blinded dermatologist raters who are asked to evaluate the appearance of the ecchymoses from digital photographs using a visual analog scale.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Northwestern University

Dates:
Date Received: August 10, 2006
Date Started: July 2006
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014