NCT03876548

Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision

Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Next Science TM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.

Detailed description

The objective of this 6 month, interventional, open label prospective pilot study is to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision. Adults 18 years and older with an established diagnosis of keloid scar formation, scheduled to undergo keloid scar revision surgery, and who meet the protocol's inclusion and exclusion criteria are eligible for this study. There will be a minimum of 20 completed subjects with up to 30 enrolled. After keloid revision surgery, subjects will apply product every other day for one month. There will be a total of 5 study visits: Visit 0 (Revision Surgery Date and Start of Treatment); Visit 1 (1 Week Post-Revision); Visit 2 (4 Weeks Post-Revision); Visit 3 (12 Weeks Post Revision); and Visit 4 (24 Weeks Post-Revision and Study Exit). Imaging, Patient and Observer Scar Assessment Scale questionnaires, and Dermatological Life Quality Index Questions will be collected. It is hypothesized that there will be a measurable reduction in the amount (number, size) of keloid formation and/or recurrence at 4, 12, and 24 weeks post revision surgery time points. The change in subjects' quality of life as measured by the the Dermatology Quality of Life Index will also be assessed.

Conditions

• Keloid Scar Following Surgery

Interventions

Type	Name	Description
DEVICE	Cadexomer Iodine Gel	Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.

Timeline

• Start date: 2019-02-07
• Primary completion: 2019-06-01
• Completion: 2019-06-30
• First posted: 2019-03-15
• Last updated: 2019-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study