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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.

Phase 2
18 Years
Not Enrolling

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Trial Information

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.

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Principal Investigator

Stuart R. Lessin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

April 2001

Completion Date:

August 2004

Related Keywords:

  • Parapsoriasis
  • Parapsoriasis
  • Cutaneous T-cell lymphoma
  • Mycosis fungoides
  • Bexarotene
  • Retinoids
  • Parapsoriasis
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111