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N/A N=16 Randomized Double-blind Treatment

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

Ecchymosis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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