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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
Enrollment 3
Recruitment Details  
Pre-assignment Details All participants enrolled required 2 similar calcinosis lesions; one for the treatment arm and one for the no treatment arm.
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description

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.

Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
Period Title: Overall Study
Number of participants Number of units (lesion) Number of participants Number of units (lesion)
Started 3 3 3 3
Completed 2 2 2 2
Not Completed 1 1 1 1
Reason Not Completed
Physician Decision             1                         1            
Arm/Group Title All Study Participants
Hide Arm/Group Description This Arm includes all participants who were enrolled in the study
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 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%
1.Primary Outcome
Title Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales.
Hide Description Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Physician Calcinosis Visual Analog Scales. The Visual Analog Scale range is from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative percent change indicates improvement in the lesion.
Time Frame Change from Visit 2 to Visit 12 (week 20)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description:

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.

Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
Overall Number of Participants Analyzed 2 2
Overall Number of Units Analyzed
Type of Units Analyzed: Lesion
2 2
Measure Type: Number
Unit of Measure: percentage change
Subject 1 -38.0 3.3
Subject 2 -53.1 2.0
2.Secondary Outcome
Title 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.
Hide Description 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. The range of a durometer is from 0 to 100. The higher the durometer reading, the harder the lesion. Improvement in the lesion hardness would result in a negative change over time.
Time Frame Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2 subjects were enrolled and each subject has 2 lesions that were followed through the study. Each subject has one area that was marked as treatment lesion and also has an area that was used as a control (no treatment lesion). Overall, there were 2 subjects, 2 treatment lesions and 2 no treatment lesions.
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description:
Lesion A, target lesion Fractionated Carbon Dioxide (FCO2) Laser
Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
Overall Number of Participants Analyzed 2 2
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
2 2
Measure Type: Number
Unit of Measure: percentage of change
Subject 1 -35.8 -18.4
Subject 2 7.4 23.8
3.Secondary Outcome
Title Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales.
Hide Description Change in dermatomyositis-associated calcinosis of a single lesion by assessing its severity as measured by a difference in Patient Calcinosis Visual Analog Scales. The scale ranges from zero (0) to ten (10). Zero (0) being no evidence of disease activity and ten (10) being extremely active or severe disease activity. A negative change would indicate improvement in the disease activity. A positive change would indicate worsening of disease activity.
Time Frame Change from Visit 2 to Visit 12 (week 20)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description:

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.

Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
Overall Number of Participants Analyzed 2 2
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
2 2
Measure Type: Number
Unit of Measure: Percentage of change
Subject 1 104.7 136.5
Subject 2 0 1.9
4.Secondary Outcome
Title Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies.
Hide Description Change in dermatomyositis-associated calcinosis as measured by a difference in centimeters in plain film (x-ray) studies. X rays were compared between baseline and final assessment for any changes.
Time Frame Change from Visit 2 to Visit 12 (week 20)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No change was observed for any lesion.
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description:
Lesion A, target lesion
Lesion B, similar area of calcinosis on the same patient, which did not receive treatment
Overall Number of Participants Analyzed 2 2
Overall Number of Units Analyzed
Type of Units Analyzed: Lesion
2 2
Mean (Standard Deviation)
Unit of Measure: cm
0  (0) 0  (0)
5.Secondary Outcome
Title Change in Patient Functionality and/or Quality of Life.
Hide Description This will be assessed through the use of the Dermatology Life Quality Index (DLQI), Health Assessment Questionnaire (HAQ)/Childhood Health Assessment Questionnaire (CHAQ), Manual Muscle Testing (MMT8), and range of motion evaluations. DLQI index scores range from 0 to 30. The higher the score, the more quality of life is impaired.Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in DLQI. HAQ scales range from 0 to 3. The higher the score, the greater the disability. Change in scores from baseline to final assessment yielding a negative percent change indicate an improvement in the HAQ. MMT8 testing results in a score between 0 and 150. The higher the score, the more normal the function of the muscle. A positive percent change would indicate an improvement in MMT8 testing results.
Time Frame Change from Visit 1 to Visit 12 (week 20)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The arms/groups does not apply to this outcome measure. Lesions were not analyzed in these assessments. Overall Patient functionality and quality of life were evaluated via questionnaires, manual muscle testing, and range of motion evaluations. No changes in range of motion were noted for either subject.
Arm/Group Title Treatment Lesion
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of change from baseline
DLQI : Subject 1 -37.5
DLQI : Subject 2 57.1
HAQ : Subject 1 -44.4
HAQ : Subject 2 0
MMT8 : Subject 1 3.4
MMT8 : Subject 2 -6.7
Time Frame Adverse events were collected during the subjects' participation in the study, over a 6 month period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Lesion No Treatment Lesion
Hide Arm/Group Description

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.

Lesion B, similar area of calcinosis on the same patient, which did not receive treatment, is evaluated.
All-Cause Mortality
Treatment Lesion No Treatment Lesion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Lesion No Treatment Lesion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment Lesion No Treatment Lesion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/3 (0.00%) 
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
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