Phase 3
N=288
Maintenance Effect of Clobex Shampoo on Participants With Moderate to Severe Scalp Psoriasis
Scalp Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT00400725 ↗Enrolled (actual)
288
Serious AEs
2.0%
Results posted
Jul 2023
Primary outcome: Primary: Maintenance Phase: Time to First Relapse — 93.5; 56.8 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clobex® Shampoo (Drug); Clobex® Vehicle Shampoo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Aug 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maintenance Phase: Time to First Relapse |
93.5; 56.8 | — |
| SECONDARY Initial Phase: Percentage of Participants With Global Severity Scores |
0; 0; 0; 58.3; 41.7; 2.4 | — |
| SECONDARY Initial Phase: Percentage of Participants With Pruritus Scores |
3.8; 20.8; 51.7; 23.6; 19.8; 53.5 | — |
| SECONDARY Initial Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores |
0; 1.7; 47.2; 45.5; 5.6; 2.4 | — |
| SECONDARY Maintenance Phase: Percentage of Participants Who Had First Relapse |
0; 0; 41; 64.5; 52.8; 76.6 | — |
| SECONDARY Maintenance Phase: Percentage of Participants With Scalp Psoriasis Pruritus Score at First Time of Relapse |
13.2; 7.2; 29.4; 26.8; 51.5; 52.6 | — |
| SECONDARY Maintenance Phase: Percentage of Participants With Individual Category of Scalp Psoriasis Individual Signs (Erythema, Scaling and Plaque Thickening) Scores at First Time of Relapse |
1.5; 0; 13.2; 13.4; 57.4; 54.6 | — |
| SECONDARY Maintenance Phase: Percentage of Participants With Number of Relapses Experienced |
31.1; 8.1; 26.4; 22.5; 9.4; 25.2 | — |
Summary
The objective of the study was to assess the maintenance effect on scalp psoriasis of Clobex® Shampoo 0.05% when used twice weekly.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects aged 18 years or older.
- Subjects with moderate to severe scalp psoriasis
Exclusion Criteria
- Subjects who needed systemic treatment for their body psoriasis
- Subjects with a washout period for topical treatment(s) on the scalp less than:
- Corticosteroids 2 weeks
- All other anti-psoriasis medications 2 weeks
- Subjects with a washout period for systemic treatment(s) less than:
- PUVA therapy 4 weeks
- Biological therapies 12 weeks
- Treatments other than biologicals with a possible efficacy on psoriasis 4 weeks
- Treatment known to worsen psoriasis 2 weeks
Data sourced from ClinicalTrials.gov (NCT00400725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.