A Phase 2 interventional study of Dupilumab in Keloid, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Beth Israel Deaconess Medical Center · Phase 2, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dupilumab
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.
Also known as: Dupixent
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).
Time frame: Baseline and Week 24
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 1. Score 0: normal color and capillary refill 2. Score 1: pink scar with a slight increase in the local blood supply 3. Score 2: red scar with a significant increase in the local blood supply 4. 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)
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: Baseline and Week 24
| Milestone | Dupilumab Subcutaneous Injection |
|---|---|
| Started | 20 |
| Completed | 14 |
| Not completed | 6 |
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).
| score on a scale | Dupilumab Subcutaneous Injection |
|---|---|
| Week 0 (Baseline) | 78 (67 to 84) |
| Week 24 (EOS) | 65 (42 to 70) |
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 1. Score 0: normal color and capillary refill 2. Score 1: pink scar with a slight increase in the local blood supply 3. Score 2: red scar with a significant increase in the local blood supply 4. 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)
| Score on a scale | Dupilumab Subcutaneous Injection |
|---|---|
| Week 0 (Baseline) | 8 (6 to 9) |
| Week 24 (EOS) | 7 (4 to 8) |
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
| score on a scale | Dupilumab Subcutaneous Injection |
|---|---|
| Week 0 (Baseline) | 3 (1 to 4) |
| Week 24 (EOS) | 1 (0 to 3) |
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).
| Arbitrary units (AU) | Dupilumab Subcutaneous Injection |
|---|---|
| aSMA (Baseline) | 25.5 (14.725 to 41.775) |
| aSMA (Week24) | 19.7 (13.5 to 27) |
| Collagen I (Baseline) | 194.9 (148.65 to 229.9) |
| Collagen I (Week 24) | 233.7 (191.15 to 240.17) |
| HSP47 (Baseline) | 55.7 (41.77 to 56.83) |
| HSP47 (Week 24) | 39.3 (33.47 to 53.35) |
| TGFbeta (Baseline) | 2.4 (2.23 to 2.57) |
| TGFbeta (week 24) | 1.5 (1.1 to 1.75) |
| IL-4R⍺ (Baseline) | 50.1 (41.47 to 56.2) |
| IL-4R⍺ (Week 24) | 49.1 (38.4 to 56.27) |
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.
| cubic centimeter | Dupilumab Subcutaneous Injection |
|---|---|
| Mean Change in Volume of Keloid to Show Improvement | -0.037 ± 0.106 |
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).
| Cell count/HPF [x200] | Dupilumab Subcutaneous Injection |
|---|---|
| Mast Cell Tryptase (Baseline) | 31.0 (30.7 to 33.85) |
| Mast Cell Tryptase (Week 24) | 39.20 (31.4 to 48.95) |
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).
| Percentage of cells | Dupilumab Subcutaneous Injection |
|---|---|
| pSTAT3 (Baseline) | 21.7 (15.7 to 29.9) |
| pSTAT3 (Week 24) | 20.30 (12.87 to 25.47) |
| pSTAT6 (Baseline) | 86.4 (72.23 to 89.97) |
| pSTAT6 (Week 24) | 84.30 (77.07 to 86.23) |
Collected over Adverse events were collected over a 26 week period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dupilumab Subcutaneous Injection | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Dupilumab Subcutaneous Injection |
|---|---|
| Median | 27.3 (24.6 to 34.5) |
| Sex/Gender, Customized(Participants) | Dupilumab Subcutaneous Injection |
|---|---|
| Female | 13 |
| Male | 6 |
| Other | 1 |
| Ethnicity (NIH/OMB)(Participants) | Dupilumab Subcutaneous Injection |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 17 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Dupilumab Subcutaneous Injection |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 8 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2023 to primary completion in May 2025, 28 months.
Results were first posted in Sep 2026, 1 year 3 months after primary completion.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dupilumab
Beth Israel Deaconess Medical Center →