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

Primary Purpose

Ecchymosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Petrolatum United States Pharmacopeia (USP)
Vitamin K and retinol ointment
Arnica ointment
Vitamin K ointment
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ecchymosis focused on measuring Bruising, Topical 20% arnica

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bruising

Arm Description

Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
August 10, 2006
Last Updated
December 1, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00363038
Brief Title
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Official Title
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ecchymosis
Keywords
Bruising, Topical 20% arnica

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bruising
Arm Type
Experimental
Arm Description
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Petrolatum United States Pharmacopeia (USP)
Intervention Description
Topical formation applied to bruise twice daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin K and retinol ointment
Intervention Description
Topical formation applied to bruise twice daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Arnica ointment
Intervention Description
Topical formation applied to bruise twice daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin K ointment
Intervention Description
Topical formation applied to bruise twice daily for 2 weeks.
Primary Outcome Measure Information:
Title
Average Bruise Change
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20412090
Citation
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.
Results Reference
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Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

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