NCT04988022

Dupilumab in the Treatment of Keloids

Completed Phase 4 Last updated 4 July 2025

What this trial tests

Phase 4 trial testing Dupilumab in Keloid in 44 participants. Completed in 24 March 2025.

Timeline

25 May 2021

Primary endpoint
24 March 2025

24 March 2025

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	44
Start date	25 May 2021
Primary completion	24 March 2025
Estimated completion	24 March 2025
Sites	1 location across United States

Drugs / interventions tested

• Dupilumab (DUPILUMAB) — full drug profile →
• Placebo

Conditions studied

• Keloid — all drugs for Keloid →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Keloid. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a prospective, randomized, double blind, placebo-controlled clinical trial.

The study will include a total of 44 subjects with clinically measurable keloid lesions. At least 50% of subjects (at least 22 out of the 44 subjects) will also have documented diagnosis of concomitant type 2 atopic/allergic) inflammatory diseases. In Phase I, subjects will be randomized (3:1) to either receive weekly dupilumab or placebo for 24 weeks. At Week 24, both groups will enter Phase II of the study in which all subjects will receive weekly doses of dupilumab up to Week 52. The treatment period will conclude at Week 52.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Dupilumab in Inflammatory Skin Diseases: A Systematic Review.
   Olbrich H, Sadik CD, Ludwig RJ, Thaçi D, et al · · 2023 · cited 67× · PMID 37189381 · DOI 10.3390/biom13040634
2. Modelling and targeting mechanical forces in organ fibrosis.
   Mascharak S, Guo JL, Griffin M, Berry CE, et al · · 2024 · cited 23× · PMID 39552705 · DOI 10.1038/s44222-023-00144-3
3. Fibrosis in burns: an overview of mechanisms and therapies.
   Faour S, Farahat M, Aijaz A, Jeschke MG. · · 2023 · cited 21× · PMID 37811732 · DOI 10.1152/ajpcell.00254.2023
4. Clinical, mechanistic, and therapeutic landscape of cutaneous fibrosis.
   Li DJ, Berry CE, Wan DC, Longaker MT. · · 2024 · cited 14× · PMID 39321265 · DOI 10.1126/scitranslmed.adn7871
5. Treatment of lichen sclerosus and hypertrophic scars with dupilumab.
   Peterson DM, Damsky WE, Vesely MD. · · 2022 · cited 13× · PMID 35445148 · DOI 10.1016/j.jdcr.2022.03.002
6. Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov.
   Park S, Li D, Guo L, Xu X. · · 2026 · PMID 42077711 · DOI 10.7759/cureus.106243
7. Exploring the Complexities of TGF-β Signaling in Keloids: Beyond the Classical Smad Pathway.
   Mo J, Huang H, Zhu B, Liao R, et al · · 2026 · PMID 42074238 · DOI 10.3390/ijms27083600
8. Immune cells in keloids: mechanisms and potential treatments.
   Wu Y, Huang Y, Zhang H, Dong C, et al · · 2026 · PMID 41964275 · DOI 10.1080/07853890.2026.2655499