Tapinarof for Cutaneous Lupus Erythematosus

Conditions

• Cutaneous Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Tapinarof — DRUG
  A thin layer of tapinarof cream is applied to affected areas once daily.

Study Details

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.

Key Dates

Start date

Apr 3, 2025

Status verified

Apr 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tapinarof Treatment
  CLE participants treated with tapinarof

Primary Outcome Measure

Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score [ Time Frame: 16 weeks ]

Locations (1)

Find similar trials in Chicago, IL

Related Studies

• A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
  PHASE3 · Recruiting · EMD Serono Research & Development Institute, Inc. · Upland, California