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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ecchymosis

Intervention / Treatment
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* Drug: Petrolatum United States Pharmacopeia (USP)
* Drug: Vitamin K and retinol ointment
* Drug: Arnica ointment
* Drug: Vitamin K ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bruising<br>Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks. | Drug: Petrolatum United States Pharmacopeia (USP)<br>* Topical formation applied to bruise twice daily for 2 weeks.<br>Drug: Vitamin K and retinol ointment<br>* Topical formation applied to bruise twice daily for 2 weeks.<br>Drug: Arnica ointment<br>* Topical formation applied to bruise twice daily for 2 weeks.<br>Drug: Vitamin K ointment<br>* Topical formation applied to bruise twice daily for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bruising, Topical 20% arnica