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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03079531
Recruitment Status : Completed
First Posted : March 14, 2017
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Anne Chang, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: Secukinumab Phase 1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Phase 1b Study of Secukinumab in Patients With Moderate to Severe Papulopustular Rosacea
Actual Study Start Date : June 21, 2017
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
Drug Information available for: Secukinumab

Arm Intervention/treatment
Experimental: Secukinumab arm
Participants receive secukinumab (7 doses over a 16-week study period).
Drug: Secukinumab
Secukinumab 300 mg administered subcutaneously.
Other Name: Tremfya




Primary Outcome Measures :
  1. Change From Baseline in Papule/Pustule Count at Week 16 [ Time Frame: Baseline, week 16 ]
    The total number of papules and pustules on the patient was assessed.


Secondary Outcome Measures :
  1. Change From Baseline Papule/Pustule Count at Week 12 [ Time Frame: Baseline, week 12 ]
    The total number of papules and pustules on the patient was assessed.

  2. Change From Baseline in Clinician's Global Severity Score for Rosacea at Week 16 [ Time Frame: Baseline, week 16 ]
    Scale range: 0-4 (0=none to very mild; 1=mild; 2=moderate; 3=severe; 4=very severe).

  3. Change From Baseline in Clinician's Global Erythema Assessment Score at Week 16 [ Time Frame: Baseline, week 16 ]
    Scale range: 0-4 (0=none; 1=mild; 2=moderate; 3=significant; 4=severe).

  4. Change From Baseline in Rosacea Quality of Life (RosaQoL) Score at Week 16 [ Time Frame: Baseline, week 16 ]
    Scale range: 0-5 with greater scores denoting worse quality of life.

  5. Count of Participants With ≥ Grade 3 Adverse Events [ Time Frame: 16 weeks ]
  6. Change From Baseline in Immune Infiltrates in Papulopustular Rosacea Lesions at Week 16 [ Time Frame: Baseline, 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079531


Locations
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United States, California
Stanford Dermatology
Redwood City, California, United States, 94603
Sponsors and Collaborators
Anne Chang
Investigators
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Principal Investigator: Anne Chang, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Anne Chang, Stanford University:
Publications:
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Responsible Party: Anne Chang, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03079531    
Other Study ID Numbers: e-protocol 38599
First Posted: March 14, 2017    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rosacea
Skin Diseases