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

NCT00363038 | Completed Results

• 1 other identifier: 1253-015
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Ecchymosis

Keywords

Bruising; Topical 20% arnica

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bruising

EXPERIMENTAL

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

Drug: Petrolatum United States Pharmacopeia (USP); Drug: Vitamin K and retinol ointment; Drug: Arnica ointment; Drug: Vitamin K ointment

Interventions

Petrolatum United States Pharmacopeia (USP) DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Bruising

Vitamin K and retinol ointment DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Bruising

Arnica ointment DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Bruising

Vitamin K ointment DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Bruising

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related 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.

  PMID: 20412090 BACKGROUND

MeSH Terms

Conditions

Ecchymosis; Contusions

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Wounds, Nonpenetrating; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Limitations and 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.

Results Point of Contact

• Title: Murad Alam, MD
• Organization: Northwestern University Department of Dermatology

m-alam@northwestern.edu

312-695-6785

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: December 3, 2021
• Results First Posted: December 4, 2012

Record last verified: 2021-12

Locations

US (1)