Clinical trial · Interventional
Phase II Trial to Evaluate the Efficacy of Topical Bexarotene Gel in Patients With Parapsoriasis
A Phase II Trial to Evaluate the Efficacy of Topical Bexarotene Gel in Patients With Parapsoriasis: a Topical Chemoprevention Strategy for Cutaneous T-cell Lymphoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The response rate (5/8) had reached a statistical significant endpoint.
Summary
Brief summary (as posted)
Parapsoriasis is a term that refers to a precursor stage of cutaneous T-cell lymphoma (CTCL)/mycosis fungoides(MF). Complete responses (clearing) of early presentations of CTCL/MF have been shown to be associated with long-term survival and cure. Induction of a complete response in parapsoriasis, therefore, would seem to be a desirable therapeutic endpoint. Bexarotene 1% gel has been approved for treatment of cutaneous T-cell lymphoma (mycosis fungoides). The goal of this study is to evaluate the tolerability, safety and efficacy of bexarotene 1% gel in patients with parapsoriasis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parapsoriasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bexarotene 1% gel | Drug | Bexarotene | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The primary efficacy endpoints (outcome) are the skin lesion responses determined by the Composite Assessment of Index Lesion Disease Severity following up to sixteen weeks of treatment
Secondary outcomes (2)
- measure
- Secondary efficacy endpoints (outcomes) include the disease response to treatment as determined by percentage of total body surface area involvement and physician global assessment following up to sixteen weeks of treatment.
- measure
- Also, antitumor host response as determined by immunohistochemistry in pre and post treatment skin biopsies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A clinical and histologic diagnosis of parapsoriasis (T0 CTCL) * Age 18 years or older. * Acceptable laboratory studies * Must be free of serious concurrent illness. * Women of child-bearing potential must have negative serum pregnancy test prior to the initiation of treatment. Exclusion Criteria: * Topical or systemic therapies within four weeks of entry in the study. * Participation in any other investigational drug study within thirty days of entry in this study. * Oral retinoid therapy for any indication within three months of entry in the study. * Participation in any other study using topical retinoid therapy. * Pregnancy or active breast-feeding. * Serious known concurrent medical illness or infection.
References
Publications (0)
Data not yet available