Trial · NCT01572844
Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
NCT01572844, Phase 2, Completed, Alison Ehrlich; results first posted 2017-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis. Trials, record NCT01572844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01572844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
- NCT number
- NCT01572844
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Alison Ehrlich
- Conditions
- Calcinosis
- Interventions
- Fractionated Carbon Dioxide (FCO2) Laser, Sodium thiosulfate
- First posted
- 2012-04-06
- Last updated
- 2017-11-29
- Results first posted
- 2017-11-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | Change from Visit 2 to Visit 12 (week 20) | 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. |
| 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. | Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20). | 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. |
| 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. | Change from Visit 2 to Visit 12 (week 20) | 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. |
| Secondary | Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies. | Change from Visit 2 to Visit 12 (week 20) | 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. |
| Secondary | Change in Patient Functionality and/or Quality of Life. | Change from Visit 1 to Visit 12 (week 20) | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Change from Visit 2 to Visit 12 (week 20) | percentage change | NUMBER | |
| 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. | Change from Baseline (Visit 1) at Final Assessment (Visit 12, week 20). | 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. | percentage of change | NUMBER |
| 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. | Change from Visit 2 to Visit 12 (week 20) | Percentage of change | NUMBER | |
| SECONDARY | Change in Size of Dermatomyositis-associated Calcinosis Area on Lesions as Measured by a Difference in Plain Film (X-ray) Studies. | Change from Visit 2 to Visit 12 (week 20) | No change was observed for any lesion. | cm | MEAN |
| SECONDARY | Change in Patient Functionality and/or Quality of Life. | Change from Visit 1 to Visit 12 (week 20) | 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. | percentage of change from baseline | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. | Treatment Lesion | Subject 1 | -38.0 | percentage change | |
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. | No Treatment Lesion | Subject 1 | 3.3 | percentage change | |
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. | Treatment Lesion | Subject 2 | -53.1 | percentage change | |
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales. | No Treatment Lesion | Subject 2 | 2.0 | percentage change | |
| 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. | Treatment Lesion | Subject 1 | -35.8 | percentage of change | |
| 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. | No Treatment Lesion | Subject 1 | -18.4 | percentage of change | |
| 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. | Treatment Lesion | Subject 2 | 7.4 | percentage of change | |
| 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. | No Treatment Lesion | Subject 2 | 23.8 | percentage of change | |
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales. | Treatment Lesion | Subject 1 | 104.7 | Percentage of change | |
| Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Patient Calcinosis Visual Analog Scales. | No Treatment Lesion | Subject 1 | 136.5 | Percentage of change |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Lesion | 3 | 3 |
| Overall Study | STARTED | No Treatment Lesion | 3 | 3 |
| Overall Study | COMPLETED | Treatment Lesion | 2 | 2 |
| Overall Study | COMPLETED | No Treatment Lesion | 2 | 2 |
| Overall Study | NOT COMPLETED | Treatment Lesion | 1 | 1 |
| Overall Study | NOT COMPLETED | No Treatment Lesion | 1 | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Lesion | 0 | 3 |
| Total, all-cause mortality | No Treatment Lesion | 0 | 3 |
| Total, other adverse events | Treatment Lesion | 0 | 3 |
| Total, other adverse events | No Treatment Lesion | 0 | 3 |
| Total, serious adverse events | Treatment Lesion | 0 | 3 |
| Total, serious adverse events | No Treatment Lesion | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Lesion vs No Treatment Lesion: deaths from any cause | Trial comparisons |
| Treatment Lesion vs No Treatment Lesion: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01572844
GET https://conductscience.org/api/trials/v1/NCT01572844/registered