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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The study investigates the efficacy and safety of dupilumab in the treatment of keloids
Current scar treatments have limited efficacy and are often unsatisfactory although over $20 billion dollars are spent annually on the treatment and management of scars. Keloids, an abnormal proliferation of scar tissue, can be disfiguring, functionally impairing, and have dramatic impacts on quality of life. Treatments of keloids include a variety of modalities (i.e. intralesional steroid injections, silicone gel or sheets, surgery, laser, radiation therapy, cryotherapy, topical imiquimod, and intralesional 5-fluorouracil injections). However, current treatments are limited to primarily localized interventions.
The Investigators hypothesize that dupilumab can decrease the size and symptoms of keloids and improve patient's quality of life. An open-label proof of concept study regarding the use of dupilumab in patients with keloids may be the first step in elucidating a novel systematic approach to treatment of keloids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab Subcutaneous Injection | Experimental | 600 mg at initial visit and 300mg every 2 weeks until week 22 Each subject will receive 600mg of Dupilumab at baseline visit and 300mg of Dupilumab as a subcutaneous injection every 2 weeks for a total of 9 doses over 22 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Dupilumab a human monoclonal antibody of the immunoglobulin G4 subclass that inhibits interleukin (IL)-4 and IL-13 signaling by specifically binding to the IL-4 receptor alpha subunit, which is shared by the IL-4 and IL-13 receptor complexes. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Observer Scar Assessment Scale (POSAS) | Average patient scores for Patient and Observer Scar Assessment Scale (POSAS) from baseline and week 24. The POSAS measures scar quality by evaluating visual (e.g. color), tactile (e.g. pliability) and sensory (e.g. itch) characteristics of the scar from the perspective of the observer (investigator) and patients. POSAS is comprised of two numeric scales: the Patient Scar Assessment Scale (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60). | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Vancouver Scar Scale (VSS). | Average score of patients for Vancouver Scar Scale (VSS) from baseline and week 24. Score Description: The VSS measures four parameters of scars: vascularity, pigmentation, pliability, and height. Each parameter contained ranked subscales that may be summed to obtain a total score ranging from 0 (representing normal skin) to 13 (representing worst scar imaginable).
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Porter, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2026 | May 29, 2026 | 7 | ||
| Jun 10, 2026 |
| ID | Term |
|---|---|
| D007627 | Keloid |
| D017439 | Cicatrix, Hypertrophic |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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| Baseline and Week 24 |
| Dermatology Life Quality Index (DLQI). | Average score patient-reported outcomes based on Dermatology Life Quality Index (DLQI). Score Description: A Quality of Life Score will be calculated based upon the Dermatology Life Quality Index (DLQI). The DLQI is a validated general dermatology questionnaire that consists of 10 items that assess subject health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment) (Appendix 3)12. It has been extensively used in dermatology clinical trials for atopic dermatitis. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline. | Baseline and Week 24 |
| Histology | Histology Description: Percentage Intensity of expression of the markers will be measured by an image analysis program for patients who have data for both baseline and week 24. | Baseline and Week 24 |
| Number of patients with keloid volume and size improvement | keloid volume and size improvement will be assessed based on photographs taken by Canfield camera analysis software for patients who have data for both baseline and week 24. | Baseline and Week 24 |
| Jul 6, 2026 |
| 8 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |