Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT05128383
Phase
PHASE2
Status
Completed

Conditions

  • Keloid

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

The study investigates the efficacy and safety of dupilumab in the treatment of keloids

Key Dates

Start date
Jan 13, 2023
Status verified
Aug 2025
Primary completion
May 19, 2025
Completion
Jun 10, 2025

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dupilumab Subcutaneous Injection
    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.

Primary Outcome Measure

Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Baseline and Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-

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Beth Israel Deaconess Medical Center· Boston, MA

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