Trial Outcomes & Findings for Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising (NCT NCT00363038)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Baseline and 2 weeks

Results posted on

2021-12-03

Participant Flow

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

Participant milestones

Participant milestones
Measure	Average Bruise Improvement 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.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Average Bruise Improvement n=16 Participants 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.
Age, Continuous	26 years n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Region of Enrollment United States	16 participants n=93 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Average Bruise Improvement n=16 Participants 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.
Average Bruise Change Petrolatum USP	-3.68 Units on a Scale Standard Deviation 0.68 • Interval -10.0 to 10.0
Average Bruise Change Vitamin K and retinol ointment	-3.71 Units on a Scale Standard Deviation 0.60 • Interval -10.0 to 10.0
Average Bruise Change Vitamin K ointment	-3.88 Units on a Scale Standard Deviation 0.71 • Interval -10.0 to 10.0
Average Bruise Change Arnica ointment	-4.13 Units on a Scale Standard Deviation 0.84 • Interval -10.0 to 10.0

Adverse Events

Average Bruise Improvement

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Average Bruise Improvement n=16 participants at risk 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.
Skin and subcutaneous tissue disorders Redness and swelling at the treated sites	25.0% 4/16 • Number of events 4 • 2 weeks
Skin and subcutaneous tissue disorders Blistering	6.2% 1/16 • Number of events 1 • 2 weeks

Additional Information

Murad Alam, MD

Northwestern University Department of Dermatology

Phone: 312-695-6785

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place