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

Ecchymosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363038
• Other study ID #: 1253-015
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: August 2006

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Contusions
• Ecchymosis

Intervention

Drug:
• Petrolatum United States Pharmacopeia (USP)
Topical formation applied to bruise twice daily for 2 weeks.
• Vitamin K and retinol ointment
Topical formation applied to bruise twice daily for 2 weeks.
• Arnica ointment
Topical formation applied to bruise twice daily for 2 weeks.
• Vitamin K ointment
Topical formation applied to bruise twice daily for 2 weeks.

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 2 weeks