Ecchymosis
Conditions
Keywords
Bruising, Topical 20% arnica
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.
Interventions
DRUGPetrolatum United States Pharmacopeia (USP)
Topical formation applied to bruise twice daily for 2 weeks.
DRUGVitamin K and retinol ointment
Topical formation applied to bruise twice daily for 2 weeks.
DRUGArnica ointment
Topical formation applied to bruise twice daily for 2 weeks.
DRUGVitamin K ointment
Topical formation applied to bruise twice daily for 2 weeks.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at a university-based dermatology department in an urban center.
Participants by arm
| Arm | Count |
|---|---|
| Average Bruise Improvement pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Average Bruise Improvement |
|---|---|
| Age, Continuous | 26 years |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Average Bruise Change
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).
Time frame: Baseline and 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Average Bruise Improvement | Average Bruise Change | Petrolatum USP | -3.68 Units on a Scale | Standard Deviation 0.68 |
| Average Bruise Improvement | Average Bruise Change | Vitamin K and retinol ointment | -3.71 Units on a Scale | Standard Deviation 0.6 |
| Average Bruise Improvement | Average Bruise Change | Vitamin K ointment | -3.88 Units on a Scale | Standard Deviation 0.71 |
| Average Bruise Improvement | Average Bruise Change | Arnica ointment | -4.13 Units on a Scale | Standard Deviation 0.84 |