Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
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|ClinicalTrials.gov Identifier: NCT03876548|
Recruitment Status : Withdrawn (Recruitment Challenges)
First Posted : March 15, 2019
Last Update Posted : August 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Keloid Scar Following Surgery||Device: Cadexomer Iodine Gel||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Pilot study|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study|
|Actual Study Start Date :||February 7, 2019|
|Estimated Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 30, 2019|
Experimental: Cadexomer Iodine Gel
Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.
Device: Cadexomer Iodine Gel
Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.
- Scar measurement with Silhouette Camera Imaging [ Time Frame: 24 weeks ]The keloid or keloid scar will measured using the Silhouette Camera Imaging System
- Patient and Observer Scar Assessment Scale (Subject facing) [ Time Frame: 24 weeks ]Patient and Observer Scar Assessment to be completed by the subject with the physician.
- Patient and Observer Scar Assessment Scale (Non-Subject facing) [ Time Frame: 24 weeks ]Patient and Observer Scar Assessment to be completed by the physician only.
- Response Rate calculation [ Time Frame: 24 weeks ]Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)
- Dermatology Quality of Life Index [ Time Frame: 24 Weeks ]Dermatology Quality of Life Index Questionaire
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): NCT03876548
|United States, Florida|
|Jacksonville Center for Clinical Research|
|Jacksonville, Florida, United States, 32216|
|Principal Investigator:||Michael Bernhardt, MD||Jacksonville Center For Clinical Research|