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

Not Applicable

Completed

• Conditions: Ecchymosis
• Interventions: Drug: Petrolatum United States Pharmacopeia (USP); Drug: Vitamin K and retinol ointment; Drug: Arnica ointment; Drug: Vitamin K ointment

• Registration Number: NCT00363038
• Lead Sponsor: Northwestern University

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 Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-10
• Study First Posted: 2006-08-15
• Results First Submitted: 2010-11-29
• Results First Submitted QC: 2012-11-05
• Results First Posted: 2012-12-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bruising	Vitamin K and retinol ointment	Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Bruising	Vitamin K ointment	Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Bruising	Petrolatum United States Pharmacopeia (USP)	Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Bruising	Arnica ointment	Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.

Primary Outcome Measures

Name	Time	Method
Average Bruise Change	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).

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States