An interventional study of Petrolatum United States Pharmacopeia (USP) and Vitamin K and retinol ointment in Ecchymosis, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
38 studies on the registry are indexed under Ecchymosis; 6 are open to participants now.
This study's enrollment of 16 is below the median of 66 across 34 interventional studies indexed under Ecchymosis.
Browse Ecchymosis studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Drug: Petrolatum United States Pharmacopeia (USP) · Drug: Vitamin K and retinol ointment · Drug: Arnica ointment · Drug: Vitamin K ointment
Topical formation applied to bruise twice daily for 2 weeks.
Drug pages: Vitamin K 1 · Vitamin A
Topical formation applied to bruise twice daily for 2 weeks.
Topical formation applied to bruise twice daily for 2 weeks.
Topical formation applied to bruise twice daily for 2 weeks.
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
Subjects were recruited at a university-based dermatology department in an urban center.
| Milestone | Average Bruise Improvement |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
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).
| Units on a Scale | Average Bruise Improvement |
|---|---|
| Petrolatum USP | -3.68 ± 0.68 |
| Vitamin K and retinol ointment | -3.71 ± 0.60 |
| Vitamin K ointment | -3.88 ± 0.71 |
| Arnica ointment | -4.13 ± 0.84 |
Collected over 2 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Average Bruise Improvement | — | 0/16 (0%) | 5/16 (31.3%) |
| Event | Average Bruise Improvement |
|---|---|
| Redness and swelling at the treated sitesSkin and subcutaneous tissue disorders | 4/16 |
| BlisteringSkin and subcutaneous tissue disorders | 1/16 |
| Age, Continuous(years) | Average Bruise Improvement |
|---|---|
| Mean | 26 (21 to 65) |
| Sex: Female, Male(Participants) | Average Bruise Improvement |
|---|---|
| Female | 10 |
| Male | 6 |
| Region of Enrollment(participants) | Average Bruise Improvement |
|---|---|
| United States | 16 |
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Arnicae flos extract · Vitamin K 1