A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis
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|ClinicalTrials.gov Identifier: NCT03639779|
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Calcinosis Cutis||Drug: Sodium Thiosulfate Other: Saline Solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a parallel two-arm study comparing sodium thiosulfate and saline control.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis, A Double-Blind Randomized Placebo-Controlled Trial|
|Actual Study Start Date :||November 2, 2018|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Sodium thiosulfate
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
Drug: Sodium Thiosulfate
A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
Placebo Comparator: Saline solution
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
Other: Saline Solution
A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
- Lesion Size [ Time Frame: 3 months ]The lesion size is measured in centimeters.
- Physician Global Assessment (PGA) [ Time Frame: 3 months ]The PGA will be done by the physician to assess appearance and changes in the lesion. The lesion will be assigned a score from 0 (clear) to 4 (severe).
- Visual Analog Scale (VAS) for Pain [ Time Frame: 3 months ]The VAS for pain is used to assess the pain associated with the lesion. The pain will be recorded as a number from 1 (no pain) to 10 (severe pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639779
|Contact: David Weinstein, MDemail@example.com|
|United States, Florida|
|UCF Health Lake Nona Office||Recruiting|
|Orlando, Florida, United States, 32832|
|Contact: David Weinstein, MD 407-266-4900 firstname.lastname@example.org|
|Principal Investigator: David Weinstein, MD|