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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-21

Study Completion Date

2019-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Secukinumab Treatment for Moderate to Severe Hidradenitis Suppurativa

NCT07109765

Hidradenitis Suppurativa (HS)

RECRUITING

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT03713632

Hidradenitis Suppurativa

COMPLETED PHASE3

A Randomized Trial Comparing the Efficacy and Safety of Secukinumab with Tofacitinib in the Treatment of Moderate to Severe Hidradenitis Suppurativa in Chinese Patients

NCT06707246

Hidradenitis Suppurativa

RECRUITING NA

Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa.

NCT05921994

Hidradenitis Suppurativa

ACTIVE_NOT_RECRUITING

Real-world Secukinumab Outcomes in Canadian HS Patients

NCT07282015

Hidradenitis Suppurativa

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Papulopustular Rosacea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Secukinumab arm

Participants receive secukinumab (7 doses over a 16-week study period).

Group Type EXPERIMENTAL

Secukinumab

Intervention Type DRUG

Secukinumab 300 mg administered subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Secukinumab

Secukinumab 300 mg administered subcutaneously.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tremfya

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No