A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus


About this study

The purpose of this study is to establish the effectiveness of ruxolitinib 1.5% cream BID (twice daily) in participants with cutaneous lichen planus (LP).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Clinical diagnosis of LP with predominant cutaneous involvement.

- IGA score of 3 or 4 at screening and baseline.

- Baseline LP-related Itch NRS score ≥ 4.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Concurrent conditions and history of other diseases:

1. Variants of LP deemed by the investigators to be inappropriate for topical
treatment, including but not limited to predominant mucosal (such as oral or
vaginal) LP.

2. Active ongoing inflammatory diseases of the skin other than LP that might
confound the evaluation of LP lesions or compromise participant safety.

3. Any other concomitant skin disorder (eg, generalized erythroderma such as
Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of
the investigator may interfere with the evaluation of LP lesions or compromise
participant safety.

4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or
Wiskott-Aldrich syndrome).

5. Chronic or acute infection requiring treatment with systemic antibiotics,
antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before

6. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex,
herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week
before baseline.

- Laboratory values outside of the protocol-defined criteria.

- Pregnant or lactating participants, or those considering pregnancy during the period
of their study participation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/5/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Aaron Mangold, M.D.

Open for enrollment

Contact information:

Aaron Mangold M.D.


More information


Publications are currently not available