Papulopustular Rosacea Clinical Trial
Official title:
An Open Label Phase 1b Study of Secukinumab in Patients With Moderate to Severe Papulopustular Rosacea
Verified date | January 2020 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 25, 2019 |
Est. primary completion date | January 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Dermatology | Redwood City | California |
Lead Sponsor | Collaborator |
---|---|
Anne Chang |
United States,
Blauvelt A, Prinz JC, Gottlieb AB, Kingo K, Sofen H, Ruer-Mulard M, Singh V, Pathan R, Papavassilis C, Cooper S; FEATURE Study Group. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2015 Feb;172(2):484-93. doi: 10.1111/bjd.13348. Epub 2014 Dec 11. — View Citation
Buhl T, Sulk M, Nowak P, Buddenkotte J, McDonald I, Aubert J, Carlavan I, Déret S, Reiniche P, Rivier M, Voegel JJ, Steinhoff M. Molecular and Morphological Characterization of Inflammatory Infiltrate in Rosacea Reveals Activation of Th1/Th17 Pathways. J Invest Dermatol. 2015 Sep;135(9):2198-2208. doi: 10.1038/jid.2015.141. Epub 2015 Apr 7. — View Citation
Chang ALS, Raber I, Xu J, Li R, Spitale R, Chen J, Kiefer AK, Tian C, Eriksson NK, Hinds DA, Tung JY. Assessment of the genetic basis of rosacea by genome-wide association study. J Invest Dermatol. 2015 Jun;135(6):1548-1555. doi: 10.1038/jid.2015.53. Epub 2015 Feb 19. — View Citation
Moustafa F, Hopkinson D, Huang KE, Feldman S. Prevalence of rosacea in community settings. J Cutan Med Surg. 2015 Mar-Apr;19(2):149-52. doi: 10.2310/7750.2014.14087. Epub 2015 Mar 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Papule/Pustule Count at Week 16 | The total number of papules and pustules on the patient was assessed. | Baseline, week 16 | |
Secondary | Change From Baseline Papule/Pustule Count at Week 12 | The total number of papules and pustules on the patient was assessed. | Baseline, week 12 | |
Secondary | Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 | Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe). | Baseline, week 16 | |
Secondary | Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16 | Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe). | Baseline, week 16 | |
Secondary | Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16 | Scale range: 0-5 with greater scores denoting worse quality of life. | Baseline, week 16 | |
Secondary | Count of Participants With = Grade 3 Adverse Events | 16 weeks | ||
Secondary | Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16 | Immune infiltrates as assessed by immunohistochemistry, using a semi-quantitative grading scale for histological inflammation (scale range: 0-4, with 0-normal to 4-widespread inflammation). | Baseline, week 16 |
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