Phase 3
Completed N=855
A Study Comparing Tazarotene Cream 0.05% to TAZORAC® (Tazarotene) Cream 0.05% and Both to a Placebo Control in the Treatment of Plaque Psoriasis
Source: ClinicalTrials.gov NCT02886702 ↗Enrolled (actual)
855
Serious AEs
0.4%
Results posted
Aug 2018
Primary outcomePrimary: Treatment Success Assessed by IGA — 60.8; 63.2; 56.0 Percentage of Participants — p=0.3520
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.05% to TAZORAC® (tazarotene) Cream 0.05% and Both Active Treatments to a Vehicle Control in the Treatment of Stable Plaque Psoriasis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Success Assessed by IGA |
60.8; 63.2; 56.0 | 0.3520 |
| SECONDARY Disease Severity None or Minimal on IGA |
17.5; 22.6; 16.4 | 0.8105 |
| SECONDARY Target Site Plaque Elevation, Scaling and Erythema Scores of Less Than or Equal to 1 on the PASI |
16.3; 22.2; 16.0 | 1.0000 |
Eligibility Criteria
Inclusion Criteria
- Have a definite clinical diagnosis of stable (at least 6 months) plaque psoriasis, involving at least 2% and no more than 20% of the body surface area (BSA) (not including the scalp and intertriginous areas)
- Have a minimum plaque elevation at the target lesion site of at least moderate severity (grade ≥ 3 on the Psoriasis Area Severity Index [PASI]). The most severe lesion at baseline should be identified as the target lesion
- Have an Investigator's Global Assessment (IGA) of disease severity of at least moderate (score ≥ 3) as an overall assessment of all lesions to be treated.
Exclusion Criteria
- A female subject who is pregnant, nursing, planning a pregnancy, or does not agree to use an acceptable form of birth control within the study participation period
- Have a current diagnosis of unstable forms of psoriasis in the treatment area, including pustular, guttate, exfoliative or erythrodermic psoriasis
- Have a history of psoriasis unresponsive to topical treatments
Data sourced from ClinicalTrials.gov (NCT02886702). 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. Informational only — not medical advice.