A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

A Phase 2, Randomized, Dose-Ranging, Vehicle-Controlled and Triamcinolone 0.1% Cream-Controlled Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with vehicle cream BID.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle Cream BID; Drug: Triamcinolone 0.1% Cream BID; Drug: Ruxolitinib 0.15% Cream QD; Drug: Ruxolitinib 0.5% Cream QD; Drug: Ruxolitinib 1.5% Cream QD; Drug: Ruxolitinib 1.5% Cream BID

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3A 2N1
      • INSTITUTE FOR SKIN ADVANCEMENT, 4935 40th Avenue Nw
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • DR. CHIH-HO HONG MEDICAL INC., 15300 105 Avenue
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • WISEMAN DERMATOLOGY RESEARCH INC, 6 - 1170 Taylor Avenue
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA MEDICAL RESEARCH, 95 Bayly Street West
    • Barrie, Ontario, Canada, L4M 7G1
      • SIMCODERM MEDICAL AND SURGICAL DERMATOLOGY CENTER, 5 Quarry Ridge Road
    • Markham, Ontario, Canada, L3P 1X2
      • LYNDERM RESEARCH INC, 25 Main Street Markham North
    • Mississauga, Ontario, Canada, L5H 1G9
      • DERMEDGE RESEARCH INC., 333 Lakeshore Road West
    • North Bay, Ontario, Canada, P1B 3Z7
      • NORTH BAY DERMATOLOGY CENTRE, 500 Cassells Street
    • Oakville, Ontario, Canada, L6J 7W5
      • RESEARCH BY ICLS, 1344 Cornwall Road
    • Ottawa, Ontario, Canada, K2G 6E2
      • OFFICE OF DR. MICHAEL ROBERN, 1 Centrepointe Drive
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKIN CENTRE FOR DERMATOLOGY, 775 Monaghan Road
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • YORK DERMATOLOGY CENTER, 250 Harding Blvd West
    • Toronto, Ontario, Canada, M5Sz 2B4
      • RESEARCH TORONTO, 208 Bloor Street West
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. PAPP CLINICAL RESEARCH, 135 Union Street East
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 MEDICAL RESEARCH, 2425 Tecumseh Road East
    • Windsor, Ontario, Canada, N8W 5L7
      • WINDSOR CLINICAL RESEARCH INC, 2224 Walker Road
  • Quebec
    • Saint-jerome, Quebec, Canada, J7Z 3B8
      • CLINIQUE DERMATOLOGIQUE DE SAINT-JEROME, 555 Boul. Saint-antoine
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB DERMATOLOGY, 2000 6th Avenue South
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • BURKE PHARMACEUTICAL RESEARCH, 601 W. Commerce
  • California
    • Encino, California, United States, 91436
      • ENCINO RESEARCH CENTER, 16133 Ventura Blvd
    • Los Angeles, California, United States, 90045
      • DERMATOLOGY RESEARCH ASSOCIATES,8930 South Sepulveda Blvd
    • Oceanside, California, United States, 92056
      • DERMATOLOGY SPECIALISTS, INC, 3629 Vista Way
    • Riverside, California, United States, 92506
      • INTEGRATED RESEARCH GROUP, INC, 4646 Brockton Avenue
    • San Luis Obispo, California, United States, 93405
      • SAN LUIS DERMATOLOGY AND LASER CLINIC, 15 Santa Rosa Street
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • NEW ENGLAND RESEARCH ASSOCIATES LLC, 5520 Park Avenue
  • Indiana
    • New Albany, Indiana, United States, 47150
      • DS RESEARCH, 2241 Green Valley Road
    • Plainfield, Indiana, United States, 46168
      • THE INDIANA CLINICAL TRIALS CENTER, 824 Edwards Drive
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DERMRESEARCH, 1169 Eastern Parkway 2310
    • Louisville, Kentucky, United States, 40241
      • DS RESEARCH, 3810 Springhurst Blvd
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • ACTIVMED PRACTICES & RESEARCH, INC, 138 Conant Street
    • Boston, Massachusetts, United States, 02111
      • TUFTS MEDICAL CENTER, 800 Washington Street
  • Michigan
    • Detroit, Michigan, United States, 48202
      • HENRY FORD HOSPITAL, 3031 West Grand Blvd
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • WASHINGTON UNIVERSITY - DERMATOLOGY, 4921 Parkview Place
    • Saint Louis, Missouri, United States, 63141
      • WASHINGTON UNIVERSITY - DERMATOLOGY, 969 Mason Road
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • ACTIVMED PRACTICES AND RESEARCH, INC, 110 Corporate Drive
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • HASSMAN RESEARCH INSTITUTE, LLC, 175 Cross Keys Road
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • DERMATOLOGY CONSULTING SERVICES, PLLC, 2444 North Main Street
    • Raleigh, North Carolina, United States, 27612
      • WAKE RESEARCH ASSOCIATES LLC, 3100 Duraleigh Road
  • Ohio
    • Bexley, Ohio, United States, 43209
      • DERMATOLOGISTS OF GREATER COLUMBUS, 2359 East Main Street
    • Cleveland, Ohio, United States, 44122
      • RAPID MEDICAL RESEARCH, INC, 3619 Park East Drive
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • CENTRAL SOONER RESEARCH, 900 North Porter
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • PARISH DERMATOLOGY, INC, 1845 Walnut Street
    • Upper Saint Clair, Pennsylvania, United States, 15241
      • PEAK RESEARCH LLC, 2589 Washington Rd
  • Texas
    • Arlington, Texas, United States, 76011
      • ARLINGTON RESEARCH CENTER, INC, 711 East Lamar Blvd
    • Austin, Texas, United States, 78759
      • DERMRESEARCH INC., 8140 North Mopac Expressway
    • College Station, Texas, United States, 77845
      • J&S STUDIES, INC, 1710 Crescent Pointe Pkwy
    • Houston, Texas, United States, 77004
      • CENTER FOR CLINICAL STUDIES (CCS), 1401 Binz
    • Houston, Texas, United States, 77056
      • SUZANNE BRUCE AND ASSOCIATES, PA, 1900 St. James Place
    • San Antonio, Texas, United States, 78229
      • CLINICAL TRIALS OF TEXAS, INC, 7940 Floyd Curl Drive
    • San Antonio, Texas, United States, 78229
      • DERMATOLOGY CLINICAL RESEARCH CENTER OF SAN ANTONIO, 7810 Louis Pasteur
    • Webster, Texas, United States, 77598
      • CENTER FOR CLINICAL STUDIES, 451 North Texas Avenue
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • CHARLOTTESVILLE DERMATOLOGY, 600 Peter Jefferson Parkway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants diagnosed with atopic dermatitis (AD) as defined by the Hanifin and Rajka criteria.
• Participants with a history of AD for at least 2 years.
• Participants with an Investigator's Global Assessment (IGA) score of 2 to 3 at screening and baseline.
• Participants with body surface area (BSA) of AD involvement, excluding the face and intertriginous areas, of 3% to 20% at screening and baseline.
• Participants who agree to discontinue all agents used to treat AD from screening through the final follow-up visit.

Exclusion Criteria:

• Participants with evidence of active acute or chronic infections.
• Use of topical treatments for AD (other than bland emollients) within 2 weeks of baseline.
• Systemic immunosuppressive or immunomodulating drugs (eg, oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) within 4 weeks or 5 half-lives of baseline (whichever is longer).
• Participants with other dermatologic disease besides AD whose presence or treatments could complicate the assessment of disease (eg, psoriasis).
• Participants with a history of other diseases besides dermatologic disorders (eg, other autoimmune diseases) taking treatments that could complicate assessments.

• Participants with cytopenias at screening, defined as:

  • Leukocytes < 3.0 × 10^9/L.
  • Neutrophils < lower limit of normal.
  • Hemoglobin < 10 g/dL.
  • Lymphocytes < 0.8 × 10^9/L
  • Platelets < 100 × 10^9/L.

• Participants with severely impaired liver function (Child-Pugh Class C) or end-stage renal disease (ESRD) on dialysis or at least 1 of the following:

  • Serum creatinine > 1.5 mg/dL.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 × upper limit of normal.
• Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit (topical agents with limited systemic availability are permitted).
• Participants who have previously received Janus kinase (JAK) inhibitors, systemic or topical (e.g., ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Double Blind (DB): Vehicle BID; Participants applied vehicle cream twice daily (BID) for 8 weeks DB period.	Drug: Vehicle Cream BID; Vehicle cream BID
Active Comparator: DB: Triamcinolone (TAC) 0.1% BID/Vehicle Cream BID; Participants applied triamcinolone 0.1% cream BID for 4 weeks followed by vehicle cream for 4 weeks in DB period.	Drug: Vehicle Cream BID; Vehicle cream BID; Drug: Triamcinolone 0.1% Cream BID; Triamcinolone 0.1% cream BID
Experimental: DB: Ruxolitinib 0.15% Once Daily (QD); Participants applied ruxolitinib 0.15% cream QD for 8 weeks in DB period.	Drug: Ruxolitinib 0.15% Cream QD; Ruxolitinib 0.15% cream QD; Other Names: INCB018424
Experimental: DB: Ruxolitinib 0.5% QD; Participants applied ruxolitinib 0.5% cream QD for 8 weeks in DB period.	Drug: Ruxolitinib 0.5% Cream QD; Ruxolitinib 0.5% cream QD; Other Names: INCB018424
Experimental: DB: Ruxolitinib 1.5% QD; Participants applied ruxolitinib 1.5% cream QD for 8 weeks in DB period.	Drug: Ruxolitinib 1.5% Cream QD; Ruxolitinib 1.5% cream QD; Other Names: INCB018424
Experimental: DB: Ruxolitinib 1.5% BID; Participants applied ruxolitinib 1.5% cream BID for 8 weeks in DB period.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Placebo Comparator: Open-Label (OL): Vehicle BID to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Active Comparator: OL: TAC BID/Vehicle BID to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Experimental: OL: Ruxolitinib 0.15% QD to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Experimental: OL: Ruxolitinib 0.5% QD to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Experimental: OL: Ruxolitinib 1.5% QD to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424
Experimental: OL: Ruxolitinib 1.5% BID to Ruxolitinib 1.5% BID; Following DB Period, at Week 8, participants who met criteria (compliant with the protocol and no safety concerns) received open-label treatment with ruxolitinib 1.5% cream BID for 4 weeks.	Drug: Ruxolitinib 1.5% Cream BID; Ruxolitinib 1.5% cream BID; Other Names: INCB018424

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 4 in Participants Treated With Ruxolitinib 1.5% Cream Twice a Day (BID) Compared With Participants Treated With Vehicle Cream BID	EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD Compared With Participants Treated With Vehicle Cream BID	EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.	Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 4 in Participants Treated With Ruxolitinib QD/BID Cream Compared With Participants Treated With Triamcinolone 0.1% Cream BID Followed by Vehicle	EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.	Baseline and Week 4
Mean Percentage Change From Baseline in EASI Score at Week 2 and Week 8	EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.	Baseline, Week 2 and 8
Percentage of Participants Who Achieve a ≥ 50% Improvement From Baseline in EASI (EASI-50) at Weeks 2, 4, and 8	The categorical variable EASI-50 will be equal to 1 for percentage improvement from baseline in EASI score of 50% or greater and will be equal to 0 for percentage improvement of less than 50%. This definition is introduced for the purpose of identifying participants who respond to the treatment (1 = responder, 0 = non-responder).	Week 2, 4 and 8
Percentage Change From Baseline in EASI Score at Week 4	EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). The EASI score examines 4 areas of the body and weights them for participants 8 years of age and older as follows: Head/Neck (H) = 0.1, Upper limbs (UL) = 0.2, Trunk (T) = 0.3, and Lower limbs (LL) = 0.4. The severity strata for the EASI are as follows: 0 = clear; 0.1 to 1.0 = almost clear; 1.1 to 7.0 = mild; 7.1 to 21.0 = moderate; 21.1 to 50.0 = severe; 50.1 to 72.0 = very severe. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement.	Baseline and Week 4
Time to Achieve EASI-50	Time to EASI-50 is defined as the interval between the time of randomization and the time of achieving at least 50% improvement in EASI score.	From Baseline to Week 8
Percentage of Participants Achieving an Investigator's Global Assessment (IGA) Score of 0 to 1 Who Have an Improvement of ≥ 2 Points From Baseline at Weeks 2, 4, and 8	IGA is an assessment scale used to determine severity of atopic dermatitis (AD) and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Therapeutic response was an IGA score of 0 (clear) or 1 (almost clear). An IGA responder was defined as a participant achieving an IGA score of 0 to 1 and an IGA score improvement at least 2 from baseline.	Week 2, 4 and 8
Mean Change From Baseline in the Itch Numerical Rating Scale (NRS) Score at Weeks 2, 4, and 8	The Itch NRS is a once-per-24 hours ("daily") participant-reported measure of itch intensity to rate the itching severity because of their AD by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best describes their worst level of itching in the past 24 hours. The categorical NRS is defined as 0 = None, 1 to 3 = Mild, 4 to 6 = Moderate, and 7 to 10 = Severe.	Baseline, Week 2, 4 and 8
Number of Participants With At Least One Adverse Event (AEs) and as Per Severity	AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. The severity of AEs was assessed using CTCAE v4.03 Grades 1 through 4.Data are reported for Grade 3 and higher severity for this outcome measure.	Up to Week 24

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Michael Kuligowski, MD, Incyte Corporation

Publications and helpful links

General Publications

• Gong X, Chen X, Kuligowski ME, Liu X, Liu X, Cimino E, McGee R, Yeleswaram S. Pharmacokinetics of Ruxolitinib in Patients with Atopic Dermatitis Treated With Ruxolitinib Cream: Data from Phase II and III Studies. Am J Clin Dermatol. 2021 Jul;22(4):555-566. doi: 10.1007/s40257-021-00610-x. Epub 2021 May 12.
• Kim BS, Howell MD, Sun K, Papp K, Nasir A, Kuligowski ME; INCB 18424-206 Study Investigators. Treatment of atopic dermatitis with ruxolitinib cream (JAK1/JAK2 inhibitor) or triamcinolone cream. J Allergy Clin Immunol. 2020 Feb;145(2):572-582. doi: 10.1016/j.jaci.2019.08.042. Epub 2019 Oct 17.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2017
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: eczema; Atopic dermatitis; pruritus; Janus kinase (JAK) inhibitors
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone
• Other Study ID Numbers: INCB 18424-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No