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Group A for Scalp Psoriasis

Phase 4
Waitlist Available
Led By PAUL S YAMAUCHI, MD,PhD
Research Sponsored by Paul Steven Yamauchi, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 (8 weeks after the second of two sc doses of ustekinumab)
Awards & highlights

Study Summary

This is a single site, randomized, placebo-controlled, cross-over trial of sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.The purpose of the study is to assess the effectiveness of Stelara™ (ustekinumab)in the treatment of scalp psoriasis by determining the proportion of subjects who clear or almost clear in scalp specific physician assessments. The study will include approximately 30 subjects.

Eligible Conditions
  • Scalp Psoriasis
  • Plaque Psoriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 (8 weeks after the second of two sc doses of ustekinumab)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 (8 weeks after the second of two sc doses of ustekinumab) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
s-PGA ( Scalp specific Physician Global Assessment) at Week 12

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group AActive Control2 Interventions
Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52.The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
Group II: Group BPlacebo Group2 Interventions
Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses

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Who is running the clinical trial?

Paul Steven Yamauchi, MD, PhDLead Sponsor
Janssen Services, LLCIndustry Sponsor
11 Previous Clinical Trials
740 Total Patients Enrolled
PAUL S YAMAUCHI, MD,PhDPrincipal InvestigatorClinical Science Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby May 2025