Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Average Bruise Change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Intervention: Petrolatum United States Pharmacopeia (USP) (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Intervention: Vitamin K and retinol ointment (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Intervention: Arnica ointment (Drug)
Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Intervention: Vitamin K ointment (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Murad Alam
Associate Professor of Dermatology
Northwestern University