- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00322296
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.
Study Overview
Detailed Description
Parapsoriasis is a term that refers to a red, scaling (papulosquamous) eruption on the skin characterized by its distribution (trunk and proximal extremities), asymptomatic nature and chronic course. Histologically, parapsoriasis is characterized by variable degrees of parakeratosis and epidermal spongiosis with a superficial, sparse, patchy, lichenoid infiltrate of lymphocytes and varying degrees of epidermal involvement (epidermotropism). No definitive studies have defined its etiology or epidemiology.
Historically, the term "parapsoriasis" was introduced into the dermatology literature by Brocq in 1902. Brocq used the term to clinically characterize a variety of papulosquamous eruptions that were first reported in the late 19th century. In 1905, he attempted to categorize parapsoriasis in relationship to other papulosquamous diseases of the skin. In his model, Brocq delineated a relationship between some variants of parapsoriasis (parapsoriasis en plaques or large plaque parapsoriasis) and mycosis fungoides or cutaneous T-cell lymphoma (CTCL). The first cases of mycosis fungoides (MF) were reported early in the 19th century. Progressive stages of MF ("premycotic" patch phase, plaque phase and tumor phase) were defined later in the 19th century, while the neoplastic nature of the disease remained unknown. Brocq's model sought to emphasize clinical similarities between some variants of parapsoriasis (large plaque) and early, patch phase MF.
Immunohistochemical (IHC) studies have demonstrated that parapsoriasis shares a similar immunophenotype with early stage CTCL in that the lymphocytic infiltrate is predominantly composed of CD4 lymphocytes. Polymerase chain reaction (PCR)- based T-cell receptor (TCR) gene rearrangement studies have demonstrated that parapsoriasis is a lymphoproliferative disorder characterized by the detection of clonal populations of T-cells, as is CTCL. Knowledge of the natural history of parapsoriasis stems from a series of longitudinal outcome studies published over the last 40 years. Progression to unequivocal CTCL ranged from 0% to 35% of parapsoriasis cases. Typically, cases associated with progression to CTCL tend to have larger plaques with clinical features of atrophy and/or poikiloderma.
Based on the clinicopathologic similarities of parapsoriasis and early stage CTCL, the exact nosology of parapsoriasis has been challenged, with a hypothesis that all variants of parapsoriasis (large plaque, small plaque and digitate) are synonymous with early MF. Nevertheless, parapsoriasis is recognized as a distinct precursor stage (T0N0M0) in the TNM staging schema of CTCL. T0 CTCL is defined by the presence of lesions clinically and/or histologically suggestive of CTCL.
No definitive studies have been published regarding therapy of parapsoriasis. When treated, most patients are initiated empirically on topical steroids or phototherapy. Typically, patients will have partial responses and/or relapse off any therapy. A rational therapeutic strategy for parapsoriasis is lacking because there are no longitudinal studies that correlate treatment response and impact on progression to CTCL.
Bexarotene is a resinoid, a subclass of retinoids that binds preferentially to nuclear retinoic X receptors (RXR), and has therapeutic activity in CTCL. Bexarotene 1% gel has been approved for treatment of CTCL and found to have up to a 63% response rate in Stage Ia to IIa CTCL. The goal of this study was to evaluate the tolerability, safety and efficacy of bexarotene 1% gel in patients with parapsoriasis and to evaluate the anti-tumor host response in pre- and post-treatment skin biopsies.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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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.
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Also, antitumor host response as determined by immunohistochemistry in pre and post treatment skin biopsies.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart R. Lessin, M.D., Fox Chase Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00-031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parapsoriasis
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CelgeneTerminatedHealthy Volunteers | ParapsoriasisUnited States
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AmgenCompletedParapsoriasisUnited States
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Centocor, Inc.CompletedPsoriasis | Parapsoriasis
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Assistance Publique - Hôpitaux de ParisUnknownPityriasis Lichenoides
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Cairo UniversityUnknownPityriasis LichenoidesEgypt
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Istanbul Training and Research HospitalCompletedMycosis Fungoides of SkinTurkey
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Starpharma Pty LtdCompletedRecurrent Bacterial Vaginosis (BV)
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Baylor Breast Care CenterNational Cancer Institute (NCI)Completed
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Novan, Inc.CompletedAcne VulgarisDominican Republic, Honduras, Panama
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Boston UniversityLigand PharmaceuticalsCompletedCutaneous T-Cell LymphomaUnited States
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University of Medicine and Dentistry of New JerseyLigand PharmaceuticalsCompleted