Tapinarof for Cutaneous Lupus Erythematosus

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.

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Key information

Conditions

Cutaneous Lupus Erythematosus Connective Tissue Diseases Lupus Erythematosus, Cutaneous Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years and older
Patients with a histopathological or clinical diagnosis of chronic and/or subacute CLE
Patients with at least one active cutaneous lupus lesion with a diameter ≥ 1cm and CLA-IGA-R score of ≥ 3 at screening and baseline

Exclusion criteria

Unwillingness or inability to complete informed consent process or comply with the study protocol
Patients who are pregnant or breast-feeding
Other dermatologic diseases whose presence or treatments would interfere with evaluation of the study drug or interpretation of participant safety or trial results
History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the study drug
Application to cutaneous lupus lesion(s) being assessed of topical corticosteroids, topical calcineurin inhibitors, or topical janus kinase inhibitors within 1 weeks of study drug initiation
Application to cutaneous lupus lesion(s) being assessed of topical tapinorof within 4 weeks of study drug initiation
Prior use of anifrolumab within the last 6 months
New initiation of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 12 weeks of study drug initiation
For patients already on the following treatment(s) prior to enrollment: unstable or changing of dosing of systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine, belimumab), antimalarials (hydroxychloroquine, chloroquine, quinacrine), or systemic janus kinase inhibitors within 4 weeks of study drug initiation
Patients with active infections.

Treatment and study plan

Tapinarof

Drug

A thin layer of tapinarof cream is applied to affected areas once daily.

Other names: VTAMA

Primary outcomes

Improvement in Cutaneous Lupus Activity (CLA) Investigator Global Assessment (IGA) - Revised (R) score

Time frame: 16 weeks

Proportion of participants who achieve 0 or 1 on the CLA-IGA-R scale at Week 16 (5-point Likert scale 0-4, 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe)
Improvement in the CLE Disease Area and Severity Index (CLASI)-Activity (A) score

Time frame: 16 weeks

Mean change in CLASI-A from Week 0 to Week 16.The maximum score for CLASI-A is 70 points, with a score of 0-9 indicating mild disease, 10-20 indicating moderate disease, and 21-70 indicating severe disease. A score of 0 indicates no active mucocutaneous lesions

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Oct 28, 2024
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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