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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00363038
First received: August 10, 2006
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: November 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ecchymosis
Interventions: Drug: Petrolatum United States Pharmacopeia (USP)
Drug: Vitamin K and retinol ointment
Drug: Arnica ointment
Drug: Vitamin K ointment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at a university-based dermatology department in an urban center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Average Bruise Improvement  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 USP as placebo.

Baseline Measures
    Average Bruise Improvement  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ( Full Range )
  26  
  ( 21 to 65 )  
Gender  
[units: participants]
 
Female     10  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures

1.  Primary:   Average Bruise Change   [ Time Frame: Baseline and 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Murad Alam, MD
Organization: Northwestern University Department of Dermatology
phone: 312-695-6785
e-mail: m-alam@northwestern.edu


Publications:

Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT00363038     History of Changes
Other Study ID Numbers: 1253-015
Study First Received: August 10, 2006
Results First Received: November 29, 2010
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration