Phase 2
N=24
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea
Papulopustular Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT03079531 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change From Baseline in Papule/Pustule Count at Week 16 — -5.00 papules and pustules — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Secukinumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anne Chang
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Papule/Pustule Count at Week 16 |
-5.00 | 0.01 sig |
| SECONDARY Change From Baseline Papule/Pustule Count at Week 12 |
-7.00 | 0.02 sig |
| SECONDARY Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 |
-0.33 | 0.03 sig |
| SECONDARY Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16 |
-0.33 | 0.2 |
| SECONDARY Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16 |
-0.61 | <0.001 sig |
| SECONDARY Count of Participants With ≥ Grade 3 Adverse Events |
— | — |
| SECONDARY Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16 |
0.43 | 0.56 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03079531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.