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Safety and Efficacy of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091646
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Arcutis, Inc.

Brief Summary:
This study will assess the safety and effIcacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with seborrheic dermatitis

Condition or disease Intervention/treatment Phase
Seborrheic Dermatitis Drug: ARQ-154 foam or ARQ-154 vehicle Phase 2

Detailed Description:
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to subjects with seborrheic dermatitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARQ-154 foam 0.3% Drug: ARQ-154 foam or ARQ-154 vehicle
experimental

Placebo Comparator: ARQ-154 foam Vehicle Drug: ARQ-154 foam or ARQ-154 vehicle
experimental




Primary Outcome Measures :
  1. Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: 8 Weeks ]
    Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement from Baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).


Secondary Outcome Measures :
  1. IGA Score Change [ Time Frame: Baseline, Week 2 and Week 4 ]
    Achievement of an IGA score of 'clear' or 'almost clear' plus a 2-grade improvement from Baseline at weeks 2 and 4. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

  2. Overall Assessment of Erythema Score [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Change from Baseline in Overall Assessment of Erythema score at each study visit. Achievement of an Overall Assessment of Erythema score of 0 or 1 plus a 2-grade improvement from Baseline.

  3. Overall Assessment of Scaling Score [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Change from Baseline in Overall Assessment of Scaling score at each study visit. Achievement of an Overall Assessment of Scaling score of 0 or 1 plus a 2-grade improvement from Baseline.

  4. Wi-NRS Score Change [ Time Frame: Baseline, Week 2, Week 4, Week 8 ]
    Change in WI-NRS pruritis score from Baseline. In subjects with a Baseline WI-NRS pruritis score of > 6, achievement of a > 4-point improvement from Baseline.



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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:

  1. Participants legally competent to sign and give informed consent.
  2. Males and females ages 18 years and older (inclusive) at the time of consent.
  3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
  4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas
  5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Baseline.
  6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Baseline.
  7. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
  8. Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
  9. Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
  10. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

  1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study according to Excluded Medications and Treatments
  2. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED
  3. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study
  4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
  5. Subjects with PHQ-8 >10 at Screening or Baseline visits.
  6. Previous treatment with ARQ-151 and ARQ-154.
  7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors (apremilast) within the past 4 weeks
  8. History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to PDE-4 inhibitors.
  9. Known allergies to excipients in ARQ-154 foam
  10. Known or suspected:

    • severe renal insufficiency or moderate to severe hepatic disorders
    • hypersensitivity to component(s) of the investigational products
    • history of severe depression, suicidal ideation
  11. Subjects with a history of a major surgery within 8 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study
  12. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
  13. Subjects unable to apply product to the scalp due to physical limitations.
  14. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  15. A clinically relevant history of abuse of alcohol or other drugs, at the discretion of the Investigator.
  16. Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
  17. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects.
  18. Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

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): NCT04091646


Contacts
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Contact: David Berk, MD 805-418-5006 ext 5 studyinquiry@arcutis.com

Sponsors and Collaborators
Arcutis, Inc.

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Responsible Party: Arcutis, Inc.
ClinicalTrials.gov Identifier: NCT04091646     History of Changes
Other Study ID Numbers: ARQ-154-203
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
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
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Seborrheic
Skin Diseases
Sebaceous Gland Diseases
Skin Diseases, Eczematous
Skin Diseases, Papulosquamous