Seborrheic Dermatitis (STRATUM Study)

Study Description

Brief Summary

The study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once for 8 weeks by subjects with seborrheic dermatitis.

Condition or Disease

Seborrheic Dermatitis

Study Design

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 457 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, 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
Actual Study Start Date: July 8, 2021
Actual Primary Completion Date: April 6, 2022
Actual Study Completion Date: April 6, 2022

Outcome Measures

Primary Outcome Measures

  1. Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: Week 8 ]
    IGA Success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement at Week 8. 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. In subjects with a Baseline WI-NRS pruritus score of ‚Č• 4, WI-NRS Success, defined as achievement of a ‚Č• 4-point improvement from Baseline. [¬†Time¬†Frame:¬†Week 8¬†]
    WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).
  2. In subjects with a Baseline WI-NRS pruritus score of ‚Č• 4, WI-NRS Success, defined as achievement of a ‚Č• 4-point improvement from Baseline. [¬†Time¬†Frame:¬†Week 4¬†]
    WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).
  3. In subjects with a Baseline WI-NRS pruritus score of ‚Č• 4, WI-NRS Success, defined as achievement of a ‚Č• 4-point improvement from Baseline. [¬†Time¬†Frame:¬†Week 2¬†]
    WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).
  4. IGA Success [ Time Frame: Week 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).
  5. Overall Assessment of Scaling Score [ Time Frame: Week 8 ]
    Achievement of an Overall Assessment of Scaling score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
  6. Overall Assessment of Erythema Score [ Time Frame: Week 8 ]
    Achievement of an Overall Assessment of Erythema score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3).
  7. Investigator Global Assessment Scale (IGA) Score Change [ Time Frame: Week 8 ]
    Achievement of an IGA score of ‘clear’. 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).
  8. IGA Success [ Time Frame: Week 2 ]
    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).

Eligibility Criteria

Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers: No

Inclusion Criteria

  • Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
  • Males and females ages 9 years and older at the time of consent.
  • Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
  • Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
  • An Investigator Global Assessment (IGA) disease severity of at least Moderate (‘3’) at Baseline.
  • Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate (‘2’) at Baseline.
  • 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).
  • Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
  • Subjects in good health as judged by the Investigator.
  • Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria

  • Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
  • Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
  • Previous treatment with ARQ-154 or ARQ-151.
  • Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  • Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
  • Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
ADDITIONAL DETAILS