Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine whether secukinumab is a potential therapy for those with papulopustular rosacea. We will observe whether this drug decreases the size and/or amount and severity of the pustules of those who suffer from rosacea.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anne Chang
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• moderate to severe papulopustular rosacea defined clinically using the grading system of Wilkin et al. (2004) as having at least ten lesions (either papules or pustules) on face at time of enrollment

• age 18 years or greater willing and able to understand and sign informed consent form

Exclusion Criteria:

• known hypersensitivity to secukinumab

• topical or oral anti-rosacea medication usage for 28 days prior to enrollment

• active Crohn's disease, as secukinumab may exacerbate this disease

• active infection including tuberculosis, hepatitis B or C, human immunodeficiency virus

• participants with latent tuberculosis will need to have treatment initiated prior to starting study drug

• pregnant or lactating

• active and/or uncontrolled medical conditions that may interfere with study procedures or obscure rosacea assessment such as cutaneous lupus

• use of retinoids within past 3 months of enrollment

• use of antibiotics within 4 weeks of enrollment

• use of light based or laser treatment to face within 8 weeks of enrollment

• use of topical or systemic steroids within 4 weeks of enrollment

• acne conglobate, acne fulminans, chloracne, severe acne requiring systemic treatment