N/A
N=16
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Ecchymosis
Bottom Line
View on ClinicalTrials.gov: NCT00363038 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Average Bruise Change — -3.68; -3.71; -3.88; -4.13 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Petrolatum United States Pharmacopeia (USP) (Drug); Vitamin K and retinol ointment (Drug); Arnica ointment (Drug); Vitamin K ointment (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Bruise Change |
-3.68; -3.71; -3.88; -4.13 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00363038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.