Dupilumab in the Treatment of Keloids

Keloid Clinical Trial

Official title: Defining Reversal of Keloid Lesions by Th2 Targeting With Dupilumab Treatment

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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.

After providing consent, subjects will be assessed for study eligibility during the screening period (within 28 days of Baseline), which includes a review of the subject's past and current medical conditions as well as a family history of keloids, atopic dermatitis (AD), asthma and other atopic diseases, detailed review of past and current medications, review of past topical and systemic treatments/therapies and invasive treatments (including surgery, radiation, and cryotherapy) for keloids, limited physical examination, clinical assessments (number, location and measurements via tonometer and calipers). Measurements of keloid lesions will be standardized and performed using Verneir Calipers. These are accurate to the nearest 0.01mm in their measurement of all dimensions. Keloid distensibility (hardness) will be measured using a tonometer, a tool that has been adapted for use in systemic sclerosis and can give insight into softening of lesions.

Subjects who meet inclusion criteria for eligibility will undergo Baseline assessments at Week 0, including clinical assessments (number, location and measurements via tonometer and calipers), review of concomitant medications, standardized clinical photography, questionnaires (a Dermatology Life Quality Index (DLQI), and a Keloid-Quality of Life Index (K-QLI) questionnaire), and additional skin assessments if he/she concurrently has atopic dermatitis (EASI, IGA, BSA and SCORAD will be used to evaluate existing atopic dermatitis). Blood samples and skin biopsies will be collected for mechanistic studies (described below) at various timepoints for RNA, DNA and protein analyses, as well as for analyses of IgE and serum CRP. Two 4.5 mm biopsies will be performed at Baseline: one from a keloid lesion and one from an adjacent non-lesional area. Non-lesional biopsies will mimic nascent trauma (e.g. surgery, or other inflammatory processes) and evaluate the effectiveness of dupilumab in preventing new keloid lesion formation.

Subjects will return for visits at weeks 4, 8, 16, 24, 28, 36, 48, and 52 following study treatment initiation for repeat clinical assessments (number, location, and measurements via tonometer and calipers), medication reviews, blood and biopsy collection, surveys, and monitoring for adverse events. At week 24 a second lesional biopsy will be performed (from the same keloid area biopsy at baseline, but away from the previous biopsy scar), and at week 48 both a lesional (again from the same keloid, but away from prior biopsies) and a non-lesional biopsy will be performed. Bloods will be done at baseline, week 4, week 16, week 24, week 48. The biopsy sites as well as other lesional areas will be monitored at each subsequent visit by clinical assessment (number, location and measurements via tonometer and calipers) and standardized clinical photography. ;

Related Conditions & MeSH terms

• Keloid

• NCT number: NCT04988022
• Study type: Interventional
• Source: Icahn School of Medicine at Mount Sinai
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 25, 2021
• Completion date: April 2025