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

Overview

Información sobre este estudio

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).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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
baseline.

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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Aaron Mangold, M.D.

Cerrado para la inscripción

Contact information:

Aaron Mangold M.D.

Mangold.Aaron@mayo.edu

More information

Publicaciones

Publications are currently not available
.
CLS-20541621

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