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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00363038
First received: August 10, 2006
Last updated: May 22, 2014
Last verified: May 2014

August 10, 2006
May 22, 2014
July 2006
August 2006   (final data collection date for primary outcome measure)
Average Bruise Change [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
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).
Days to resolution of ecchymoses, as determined by patient report and two double-blinded dermatologist raters who are asked to evaluate the appearance of the ecchymoses from digital photographs using a visual analog scale.
Complete list of historical versions of study NCT00363038 on ClinicalTrials.gov Archive Site
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Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

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.

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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Ecchymosis
  • Drug: Petrolatum United States Pharmacopeia (USP)
    Topical formation applied to bruise twice daily for 2 weeks.
  • Drug: Vitamin K and retinol ointment
    Topical formation applied to bruise twice daily for 2 weeks.
  • Drug: Arnica ointment
    Topical formation applied to bruise twice daily for 2 weeks.
  • Drug: Vitamin K ointment
    Topical formation applied to bruise twice daily for 2 weeks.
Experimental: Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Interventions:
  • Drug: Petrolatum United States Pharmacopeia (USP)
  • Drug: Vitamin K and retinol ointment
  • Drug: Arnica ointment
  • Drug: Vitamin K ointment
Leu S, Havey J, White LE, Martin N, Yoo SS, Rademaker AW, Alam M. Accelerated resolution of laser-induced bruising with topical 20% arnica: a rater-blinded randomized controlled trial. Br J Dermatol. 2010 Sep;163(3):557-63. doi: 10.1111/j.1365-2133.2010.09813.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2006
August 2006   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00363038
1253-015
No
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP