Clinical trial NCT05128383: Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids
Official title: An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Keloid
Keywords: keloid
keloid scar
hypertrophic scar
scar
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2021-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women between the ages of 18 and 65 at the time of dupilumab initiation.
* Subjects must have either one keloid with ≥ 2 cm length-wise or at least two keloids with ≥ 0.4 cm (width) x 0.4 cm (length)
* Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed.

Exclusion Criteria:

* History of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis (Tb) infection as defined by a positive QuantiFERON TB-Gold test at screening.
* Known infection with HIV, hepatitis B or hepatitis C at screening.
* Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 8 weeks after stopping treatment. Methods of acceptable birth control are listed below under "Women of Childbearing Potential"
* Previous hypersensitivity reaction to dupilumab.
* Patients with acute asthma, acute bronchospasm or status asthmaticus.
* Patients with known helminth infections.
* Currently on any other immunosuppressant systemic medication or within 28 days of baseline visit.
* Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
* Are participating in another study using an investigational agent or procedure during participation in this study or within 28 days prior to baseline visit.
* Any other treatment for keloids with 28 days prior to baseline visit, including silicone gel/sheets, laser therapy, intralesional steroid or 5-fluorouracil injections, topical steroid, cryotherapy, surgery, or radiation therapy.
* Has had a live vaccine

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Vancouver Scar Scale (VSS).
timeFrame: Baseline and Week 24
measure: Dermatology Life Quality Index (DLQI).
timeFrame: Baseline and Week 24
measure: Histology
timeFrame: Baseline and Week 24
measure: Number of patients with keloid volume and size improvement
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Martina Porter, MD
role: PRINCIPAL_INVESTIGATOR
References: