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

Anne Chang

Status and phase

Completed

Phase 2

Phase 1

Conditions

Papulopustular Rosacea

Treatments

Drug: Secukinumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03079531

e-protocol 38599

Details and patient eligibility

About

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.

Full description

Rosacea is a common inflammatory skin disease affecting up to 10% of adults. Despite this, the etiology of rosacea is unclear, although there may be a genetic predisposition (Chang et al., 2015). Currently, there is no cure. Rosacea can lead to scarring, itching, burning, and is associated with anxiety and depression (Moustafa et al., 2015), significantly affecting quality of life.

Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A) that is involved in inflammation. When IL-17A is bound to secukinumab, it cannot bind to its receptor, thereby inhibiting its ability to feed the inflammatory response. In clinical trials, secukinumab has been effective for moderate to severe psoriasis (Blauvelt et al., 2015). Recently, human data from all types of rosacea have shown Th1/Th17 polarization profile of the T-cell response, suggesting that anti-IL-17 therapy may be beneficial for rosacea (Buhl et al., 2015). Hence, secukinumab could be effective against rosacea. This proposal is a proof-of-concept study to use secukinumab in open label design for moderate to severe papulopustular rosacea.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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