Study Summary
This trial looks at whether the medication dupilumab is effective and safe in treating keloids.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Assessed at Screening, weeks 0, 4, 8, 12, 16, 20, 24
Week 0
Cutometer
Mexameter
Baseline and Week 24
Dermatology Life Quality Index (DLQI).
Histology
Number of patients with keloid volume and size improvement
Patient and Observer Scar Assessment Scale (POSAS)
Vancouver Scar Scale (VSS).
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
OLE Period: Dupilumab/Dupilumab
12%Accidental Overdose
2%Conjunctivitis
2%Nasopharyngitis
2%Headache
2%Dermatitis Atopic
1%Fall
1%Multiple Fractures
Trial Design
1 Treatment Group
Dupilumab Subcutaneous Injection
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Dupilumab · No Placebo Group · Phase 2
Dupilumab Subcutaneous Injection
Drug
Experimental Group · 1 Intervention: Dupilumab · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at screening, weeks 0, 4, 8, 12, 16, 20, 24
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
777 Previous Clinical Trials
844,360 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
548 Previous Clinical Trials
199,923 Total Patients Enrolled
2 Trials studying Keloid
174 Patients Enrolled for Keloid
Martina Porter, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
21 Total Patients Enrolled
Eligibility Criteria
Age 18 - 65 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Before participating in a study, subjects must be able to understand and communicate with the investigator, comply with the requirements of the study, and give written, signed, and dated consent.
People between the ages of 18 and 65 who are starting dupilumab.
to be compliant
In order to be compliant, a subject must have either one keloid with a length of ≥ 2 cm or at least two keloids with a width of ≥ 0.4 cm (length) x 0.4 cm (width).
Who else is applying?
What state do they live in?
| Connecticut | 50.0% |
| Florida | 50.0% |
How old are they?
| 65+ | 50.0% |
| 18 - 65 | 50.0% |
What site did they apply to?
| Beth Israel Deaconess Medical Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
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Conditions
Cancer Related
Treatments