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

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00363038

Purpose

The primary objective of this study is to determine the efficacy of different topical ointments compared with placebo for the resolution of post-laser induced bruising.

Condition	Intervention
Ecchymosis	Drug: Vitamin K Drug: Vitamin K and Retinol Drug: Arnica

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bruises Vitamin A Vitamin K

Drug Information available for: Retinol Vitamin A Vitamin K Arnica extract

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Days to resolution of ecchymoses, as determined by patient report and two double-blinded dermatologist raters who are asked to evaluate the appearance of the ecchymoses from digital photographs using a visual analog scale. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental Topical	Drug: Vitamin K Drug: Vitamin K and Retinol Drug: Arnica
Placebo Comparator: Petrolatum	Drug: Vitamin K Drug: Vitamin K and Retinol Drug: Arnica

Detailed Description:

The primary purpose of this study is to determine the efficacy of different topical ointments compared with placebo for the resolution of post-laser induced bruising.

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363038

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Murad Alam, MD

Northwestern University

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.

Responsible Party:	Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier:	NCT00363038 History of Changes
Other Study ID Numbers:	1253-015
Study First Received:	August 10, 2006
Last Updated:	November 17, 2010
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Ecchymosis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vitamin A
Vitamin K
Vitamins
Retinol palmitate
Micronutrients
Growth Substances

Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants
Hematologic Agents

ClinicalTrials.gov processed this record on February 12, 2012