What side effects are associated with this type of intervention?

Common treatments for keloids include corticosteroid injections, surgical removal, laser therapy, and cryotherapy. Side effects of corticosteroid injections can include skin thinning, discoloration, and the formation of small blood vessels on the skin surface. Surgical removal may lead to recurrence of keloids and potential infection. Laser therapy can cause temporary redness, swelling, and changes in skin pigmentation. Cryotherapy may result in blistering, pain, and changes in skin color. For treatments similar to Dupilumab, which targets IL-4 and IL-13 signaling, side effects can include injection site reactions, conjunctivitis, and potential allergic reactions. Further studies are needed to fully understand the efficacy and safety of Dupilumab for keloid treatment.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for keloids that target IL-4 and IL-13 signaling pathways similar to dupilumab. Traditional treatments for keloids include corticosteroid injections, surgical removal, laser therapy, and silicone sheets. Emerging treatments under investigation, such as dupilumab, aim to reduce inflammation by inhibiting specific cytokines, but further studies are needed to confirm their efficacy and safety for keloid treatment.

What other types of research exist?

Currently, the provided context does not mention any specific novel alternatives to Dupilumab for the treatment of keloids. Patients should consult with their healthcare provider to explore the latest research and treatment options available in 2024.

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Monoclonal Antibodies

Dupilumab for Keloids

Phase 2

Waitlist Available

Led By Martina Porter, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

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)

Must not have

Known infection with HIV, hepatitis B or hepatitis C at screening

Patients with known helminth infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 24

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial investigates whether dupilumab, an anti-inflammatory medication, can help patients with keloids. Keloids are excessive scar tissue growths that current treatments often fail to address effectively. By blocking proteins that cause inflammation, dupilumab may reduce keloid size and improve symptoms.

Who is the study for?

This trial is for men and women aged 18-65 with keloids, who can understand the study requirements and consent to participate. They must have at least one large keloid or multiple smaller ones but cannot be pregnant, breastfeeding, or planning pregnancy during the study. Participants should not be on immunosuppressants, have chronic infections including HIV/Hepatitis B/C, or a history of hypersensitivity to dupilumab.

What is being tested?

The trial is testing the effectiveness and safety of a medication called Dupilumab in treating keloids—overgrown scars that rise above the skin surface. The study will involve participants receiving Dupilumab under controlled conditions to see how well it works and what side effects may occur.

What are the potential side effects?

While specific side effects for this trial are not listed, Dupilumab commonly causes reactions at the injection site, eye inflammation or irritation, headache, oral herpes symptoms among others. Each person's experience with side effects may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can understand and follow the study's requirements and have signed the consent form.

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I have a keloid larger than 2 cm or at least two keloids each bigger than 0.4 cm.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV, hepatitis B, or hepatitis C.

Select...

I have a known worm infection.

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I haven't received any keloid treatments in the last 28 days.

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I have a chronic infection or tested positive for tuberculosis.

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I am currently experiencing a severe asthma attack.

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I have received a live vaccine recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient and Observer Scar Assessment Scale (POSAS)

Secondary study objectives

Dermatology Life Quality Index (DLQI).

Histology

Number of patients with keloid volume and size improvement

+1 more

Side effects data

From 2021 Phase 4 trial • 188 Patients • NCT04033367

Conjunctivitis

Headache

Dermatitis Atopic

Nasopharyngitis

Accidental Overdose

Drug Hypersensitivity

Polyarthritis

100%

80%

60%

40%

20%

Study treatment Arm

DB Period: Placebo

DB Period: Dupilumab

OLE Period: Placebo/Dupilumab

OLE Period: Dupilumab/Dupilumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dupilumab Subcutaneous InjectionExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dupilumab

FDA approved

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dupilumab works by inhibiting IL-4 and IL-13 signaling, which reduces inflammation and can potentially improve keloid symptoms. Other common treatments for keloids include corticosteroids, which reduce inflammation and collagen production, and cryotherapy, which freezes and destroys keloid tissue. These mechanisms are crucial for keloid patients as they target the excessive collagen production and inflammation that characterize keloids, thereby reducing their size and improving symptoms.