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

NCT ID: NCT00363038

Last Updated: 2021-12-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ecchymosis

Keywords

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Bruising Topical 20% arnica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bruising

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

Group Type EXPERIMENTAL

Petrolatum United States Pharmacopeia (USP)

Intervention Type DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Vitamin K and retinol ointment

Intervention Type DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Arnica ointment

Intervention Type DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Vitamin K ointment

Intervention Type DRUG

Topical formation applied to bruise twice daily for 2 weeks.

Interventions

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Petrolatum United States Pharmacopeia (USP)

Topical formation applied to bruise twice daily for 2 weeks.

Intervention Type DRUG

Vitamin K and retinol ointment

Topical formation applied to bruise twice daily for 2 weeks.

Intervention Type DRUG

Arnica ointment

Topical formation applied to bruise twice daily for 2 weeks.

Intervention Type DRUG

Vitamin K ointment

Topical formation applied to bruise twice daily for 2 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20412090 (View on PubMed)

Other Identifiers

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1253-015

Identifier Type: -

Identifier Source: org_study_id