Tapinarof for Cutaneous Lupus Erythematosus
NCT06661213 · Status: ENROLLING_BY_INVITATION · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2026-04-29
Summary
The investigators hypothesize that topical application of Tapinarof, an FDA-approved topical Aryl hydrocarbon receptor (AHR) agonist for the treatment of plaque psoriasis, would inhibit lupus-causing T cells and lead to improvement of cutaneous lupus lesions. To test this hypothesis, the investigators will perform a prospective, interventional clinical trial in patients with chronic and/or subacute cutaneous lupus. This trial will include outcomes analyzing the change in cutaneous lupus lesions using standardized assessments, but also analyze pre- and post-treatment skin and blood immune parameters to elucidate the immune effects and changes in lupus as a result of topical AHR agonist application. The goals are to 1) identify if topical AHR agonism leads to improvement in cutaneous lupus, and 2) examine the immunopathology of cutaneous lupus and its alteration with topical AHR agonist treatment.
Conditions
- Cutaneous Lupus Erythematosus
Interventions
- DRUG
-
Tapinarof
A thin layer of tapinarof cream is applied to affected areas once daily.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Paras Vakharia · Northwestern University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-03
- Primary Completion
- 2027-11-30
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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