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

This study has been completed.

First Received: August 10, 2006 Last Updated: November 19, 2009 History of Changes

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:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment
Official Title:	Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising

Resource links provided by NLM:

MedlinePlus related topics: Bruises

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.

Enrollment:	15
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2007

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

No publications provided

Study ID Numbers:	1253-015
Study First Received:	August 10, 2006
Last Updated:	November 19, 2009
ClinicalTrials.gov Identifier:	NCT00363038 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Anticarcinogenic Agents
Skin Manifestations
Antioxidants
Coagulants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Ecchymosis
Hemorrhage
Protective Agents

Hemostatics
Pharmacologic Actions
Signs and Symptoms
Fibrin Modulating Agents
Antifibrinolytic Agents
Pathologic Processes
Retinol palmitate
Therapeutic Uses
Vitamin A
Vitamins
Vitamin K
Micronutrients

ClinicalTrials.gov processed this record on November 27, 2009