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Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis

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ClinicalTrials.gov Identifier: NCT01572844
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : November 29, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
Alison Ehrlich, George Washington University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Calcinosis
Interventions: Device: Fractionated Carbon Dioxide (FCO2) Laser
Drug: Sodium thiosulfate

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants enrolled required 2 similar calcinosis lesions; one for the treatment arm and one for the no treatment arm.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (lesion)

Reporting Groups
  Description
Treatment Lesion

Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser: At each treatment visit, the target area (2cm x 2cm) (+/- 1cm) of the calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser.

Sodium thiosulfate: Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only.

Subjects will receive a total of 8-10 treatments over a 6 month period.

No Treatment Lesion Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.

Participant Flow:   Overall Study
    Treatment Lesion   No Treatment Lesion
Participants Units (lesion) Participants Units (lesion)
STARTED   3   3   3   3 
COMPLETED   2   2   2   2 
NOT COMPLETED   1      1    
Physician Decision                1                                1                 



  Baseline Characteristics

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
All Study Participants This Arm includes all participants who were enrolled in the study

Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  66.7% 
Male      1  33.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1  33.3% 
White      2  66.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales.   [ Time Frame: Change from Visit 2 to Visit 12 (week 20) ]

2.  Secondary:   Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Hardness as Measured by a Difference in Durometer (Rex Durometer Model 1600, Type OO) Measurements.   [ Time Frame: Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20). ]

3.  Secondary:   Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales.   [ Time Frame: Change from Visit 2 to Visit 12 (week 20) ]

4.  Secondary:   Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies.   [ Time Frame: Change from Visit 2 to Visit 12 (week 20) ]

5.  Secondary:   Change in Patient Functionality and/or Quality of Life.   [ Time Frame: Change from Visit 1 to Visit 12 (week 20) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alison Ehrlich, MD, Chair of Department of Dermatology
Organization: GW Medical Faculty Associates
phone: 202-741-2625
e-mail: aehrlich@mfa.gwu.edu



Responsible Party: Alison Ehrlich, George Washington University
ClinicalTrials.gov Identifier: NCT01572844     History of Changes
Other Study ID Numbers: 121131
First Submitted: April 4, 2012
First Posted: April 6, 2012
Results First Submitted: June 23, 2017
Results First Posted: November 29, 2017
Last Update Posted: November 29, 2017