KeloidPhase 2NCT05128383
Study to Assess Efficacy and Safety of Dupilumab in the Treatment of Keloids
A Phase 2 study testing Dupilumab in people with Keloid, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The study investigates the efficacy and safety of dupilumab in the treatment of keloids Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Keloid
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 10 Jun 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids
The study investigates the efficacy and safety of dupilumab in the treatment of keloids
Read the 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.
- Conditions
- Keloid
- Being tested
- Dupilumab
- Keywords
- keloid, keloid scar, hypertrophic scar, scar
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Score of Patient and Observer Scar Assessment Scale (POSAS) From Baseline to 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 (pain, pruritus, color, stiffness, thickness, bumpiness): The patient scores from 1 (normal) to 10 (worst)
- The Observer Scar Assessment Scale (vascularity, pigmentation, thickness, relief, pliability, surface area): The clinician scores each item from 1 (normal skin) to 10 (worst scar imaginable).
Both scales contain six items that are scored numerically on a 1-10 scale which are added for a total score.
The PSAS score (range of 6-60) and OSAS score (range of 6-60) are combined to get a total scoring index (range of 12-120). Higher score = worse scar and lower score = better scar (closer to normal skin).
Measured: Baseline and Week 24
Secondary outcomes (6)
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).
- Vascularity: assessed by looking at the scar at resting and by blanching the scar and observing the rate and amount of blood return
- Score 0: normal color and capillary refill
- Score 1: pink scar with a slight increase in the local blood supply
- Score 2: red scar with a significant increase in the local blood supply
- Score 3: purple scar with excess local blood supply, scars which are congested and refill slowly or cannot be completely blanched
- Pigmentation: The skin will be blanched with a piece of plastic to eliminate the effect of vascularity on skin color and compared with normal skin (Score: 0-3)
Measured: Baseline and Week 24
Dermatology Life Quality Index (DLQI).
Average score patient-reported outcomes based on 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). The scoring of each question is as follows: Very much scored = 3 points, A lot scored = 2 points, A little scored = 1, Not at all scored = 0 points, Not relevant scored = 0 points, Question 7, 'prevented work or studying' scored = 3 points.
The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 (meaning maximum impact on quality of life) and a minimum of 0 (meaning no impact of skin disease on quality of life). The higher the score, the more quality of life is impaired. 0-1 = No effect on patient's life
Measured: Baseline and Week 24
Histology
Histology Description:
To determine the effects of dupilumab on Th2 pathway molecules (IL-4 and IL-13) and selected indicators and mediators of fibrosis in keloid tissue. Tissue was collected by skin biopsy during the baseline visit (pre-intervention) and Week 24 (post-intervention). Average of the markers at Baseline and Week 24 were analyzed to determine effect.
Immunohistochemical staining was performed for the following markers: collagen I (ThermoFisher, OB1310-01, 1:200), TGF-β (Abcam, ab215715, 1:200), HSP47(Santa Cruz, sc-5293, 1:2000), αSMA (Sigma-Aldrich, A5228, 1:2000), and IL-4Ra (R\&D Systems, MAB230, 0.5 ug/mL). Staining intensity or the percentage of positive cells was analyzed using ImageJ (National Institutes of Health, Bethesda, MD).
Measured: Baseline and Week 24
Mean Change in Volume of Keloid to Show Improvement
Change in mean volume of keloid to show treatment response will be assessed based on photographs taken by Canfield camera analysis software for patients who have data for both baseline and week 24.
Measured: Baseline and Week 24
Histology - Tryptase
Histology Description:
To determine the effects of dupilumab on Th2 pathway molecules (IL-4 and IL-13) and selected indicators and mediators of fibrosis in keloid tissue. Tissue was collected by skin biopsy during the baseline visit (pre-intervention) and Week 24 (post-intervention). Average of the markers at Baseline and Week 24 were analyzed to determine effect.
Immunohistochemical staining was performed for the following markers: mast cell tryptase (GeneTex - Cat # GTX22378, 1:100). Staining intensity or the percentage of positive cells was analyzed using ImageJ (National Institutes of Health, Bethesda, MD).
Measured: Baseline and Week 24
Histology - pSTAT3 and pSTAT6
Histology Description:
To determine the effects of dupilumab on Th2 pathway molecules (IL-4 and IL-13) and selected indicators and mediators of fibrosis in keloid tissue. Tissue was collected by skin biopsy during the baseline visit (pre-intervention) and Week 24 (post-intervention). Average of the markers at Baseline and Week 24 were analyzed to determine effect.
Immunohistochemical staining was performed for the following markers: pSTAT3 (Cell Signaling Technology, CST4113, 1:50), and pSTAT6 (Abcam, ab236947, 1:2500). Staining intensity or the percentage of positive cells was analyzed using ImageJ (National Institutes of Health, Bethesda, MD).
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start13 Jan 2023
- Primary completion19 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Martina Porter, Beth Israel Deaconess Medical Center
- Investigators
- Martina Porter, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128383
- Sponsor's protocol ID
- 2021P000648
- Status last verified
- Aug 2026
- First submitted
- 26 Oct 2021
- Last updated
- 18 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No