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

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00363038
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 15.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ecchymosis	Drug: Petrolatum United States Pharmacopeia (USP); Drug: Vitamin K and retinol ointment; Drug: Arnica ointment; Drug: Vitamin K ointment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bruising Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.	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.

Outcome Measures

Primary Outcome Measures

1. Average Bruise Change [Baseline and 2 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Murad Alam, Associate Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT00363038
• Other Study ID Numbers: 1253-015
• First Posted: Aug 15, 2006
• Last Update Posted: Dec 3, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Murad Alam, Associate Professor of Dermatology, Northwestern University: Bruising; Topical 20% arnica
• Additional relevant MeSH terms: Ecchymosis; Contusions; Vitamins; Vitamin K; Vitamin A; Petrolatum

Study Results

Participant Flow

Recruitment Details	Subjects were recruited at a university-based dermatology department in an urban center.

Arm/Group Title	Average Bruise Improvement
Arm/Group Description	pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
Period Title: Overall Study
STARTED	16
COMPLETED	16
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Average Bruise Improvement
Arm/Group Description	pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
Overall Participants	16
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	26
Sex: Female, Male (Count of Participants)
Female	10 62.5%
Male	6 37.5%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Average Bruise Improvement
Arm/Group Description	pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
Measure Participants	16
Petrolatum USP	-3.68 (0.68)
Vitamin K and retinol ointment	-3.71 (0.60)
Vitamin K ointment	-3.88 (0.71)
Arnica ointment	-4.13 (0.84)

Adverse Events

Time Frame	2 weeks
Arm/Group Title	Average Bruise Improvement
Arm/Group Description	pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
All Cause Mortality
	Average Bruise Improvement
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Average Bruise Improvement
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Other (Not Including Serious) Adverse Events
	Average Bruise Improvement
	Affected / at Risk (%)	# Events
Total	5/16 (31.3%)
Skin and subcutaneous tissue disorders
Redness and swelling at the treated sites	4/16 (25%)	4
Blistering	1/16 (6.3%)	1

Limitations/Caveats

As only laser-induced bruising on the inner arm was studied, it remains to be seen if this result can be generalized to other postoperative bruises and at other anatomical sites.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.