Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05128383
Recruitment Status : Not yet recruiting
First Posted : November 22, 2021
Last Update Posted : November 22, 2021
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Martina Porter, Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment Phase
Keloid Drug: Dupilumab Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arm Intervention/treatment
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.

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.
Other Name: Dupixent




Primary Outcome Measures :
  1. Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 24 weeks ]

    To determine changes in 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 (PSAS, patient scale measuring pain, pruritus, color, stiffness, thickness, bumpiness) and the Observer Scar Assessment Scale (OSAS, observer scale measuring vascularity, pigmentation, thickness, relief, pliability, surface area). Both scales contain six items that are scored numerically on a 1-10 scale. A score of "1" being "no, not at all" and a score of "10" being "yes, very much". Together, they make up the total score (range of 12-120) of the PSAS (range of 6-60) and OSAS (range of 6-60).



Secondary Outcome Measures :
  1. Vancouver Scar Scale (VSS). [ Time Frame: 24weeks ]

    To determine changes in Vancouver Scar Scale (VSS) from baseline to 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)

  2. Dermatology Life Quality Index (DLQI). [ Time Frame: 24weeks ]

    To determine changes of patient-reported outcomes based on Dermatology Life Quality Index (DLQI).

    Score Description:

    A Quality of Life Score will be calculated based upon the 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) (Appendix 3)12. It has been extensively used in dermatology clinical trials for atopic dermatitis. The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 2 to 5 point change from baseline.


  3. Cutometer [ Time Frame: Assessed at Screening, weeks 0, 4, 8, 12, 16, 20, 24 ]

    To determine objective changes of pigmentation, erythema and pliability using by Cutometer from baseline to week 24.

    Device Description:

    The Cutometer is the device to measure elastic properties of the scars which was most frequently used in the studies for scars. This device can provide objective measurement for pliability in addition to POSAS and VSS.


  4. Mexameter [ Time Frame: Assessed at Screening, weeks 0, 4, 8, 12, 16, 20, 24 ]

    To determine objective changes of pigmentation, erythema and pliability using by Mexameter from baseline to week 24.

    Device Description:

    The Mexameter specifically measures the content of melanin (pigmentation) and only hemoglobin (erythema) in the skin. These two components are largely responsible for the skin color.


  5. Histology [ Time Frame: 24 weeks ]

    Histology Description:

    Percentage Intensity of expression of the markers will be measured by an image analysis program. Pre- and post-treatment expression levels will be compared using paired T test.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128383


Contacts
Layout table for location contacts
Contact: Hye Jin Chung, MD 6176675834 hchung6@bidmc.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Contact: Martina Porter, MD    617-671-5834    mporter3@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Martina Porter, MD Beth Israel Deaconess Medical Center
Layout table for additonal information
Responsible Party: Martina Porter, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05128383    
Other Study ID Numbers: 2021P000648
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Martina Porter, Beth Israel Deaconess Medical Center:
keloid
keloid scar
hypertrophic scar
scar
Additional relevant MeSH terms:
Layout table for MeSH terms
Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes