Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen Planus
Summary
This study is designed to demonstrate to efficacy and safety of Apremilast 20mg oral administration twice daily over 12 weeks in subjects with moderate to severe lichen planus. The hypothesis is that the subjects will achieve a significant clinical improvement in their skin disease according to a specialized physician grading scale.
Description
This is a phase 2, single center, non-randomized, open label efficacy and safety study designed to characterize the response of Apremilast 20 mg oral administered twice daily over 12 weeks in subjects with moderate to severe lichen planus. The hypothesis and ideal primary end point will be that subjects achieve significant clinical response in cutaneous disease defined as a 2 or more grade improvement of the physician global assessment (PGA) after 12 weeks of treatment.
Many various therapies have been used to treat LP including topical and oral corticosteroids, retinoids, cyclosporine, griseofulvin, dapsone and phototherapy, but often with disappointing response.4 It is an inflammatory condition whose pathogenesis involves damage to basal keratinocytes by alloreactive T cells through the release proinflammatory cytokines, such as TNF-α and IFN-γ.1 Significantly elevated levels of such inflammatory mediators are present in tissue from LP lesions compared to normal controls.5 Based on these observations, the investigation of Apremilast, due to its ability to inhibit multiple inflammatory cytokines, for the treatment of moderate to severe LP is warranted.
The primary objective of this study is to evaluate the clinical efficacy of Apremilast in subjects with moderate to severe lichen planus after 12 weeks of treatment. Other objectives are to evaluate the safety and tolerability of Apremilast, effects on quality of life, and efficacy for mucosal disease if present.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Lichen Planus
Intervention
Apremilast (CC-10004)
Location
Virginia Clinical Research Inc.
Norfolk
Virginia
United States
23507
Status
Not yet recruiting
Source
Virginia Clinical Research, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01041625
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lichen Planus, Oral
Oral lesions accompanying cutaneous lichen planus or often occurring alone. The buccal mucosa, lips, gingivae, floor of the mouth, and palate are usually affected (in a descending order of frequency). Typically, oral lesions consist of radiating white or gray, velvety, threadlike lines, arranged in a reticular pattern, at the intersection of which there may be minute, white, elevated dots or streaks (Wickham's striae). (Jablonski, Illustrated Dictionary of Dentistry)
Etretinate
An oral retinoid used in the treatment of keratotic genodermatosis, lichen planus, and psoriasis. Beneficial effects have also been claimed in the prophylaxis of epithelial neoplasia. The compound may be teratogenic.
Lichenoid Eruptions
Conditions in which there is histological damage to the lower epidermis along with a grouped chronic inflammatory infiltrate in the papillary dermis disturbing the interface between the epidermis and dermis. LICHEN PLANUS is the prototype of all lichenoid eruptions. (From Rook et al., Textbook of Dermatology, 4th ed, p398)
Parapsoriasis
The term applied to a group of relatively uncommon inflammatory, maculopapular, scaly eruptions of unknown etiology and resistant to conventional treatment. Eruptions are both psoriatic and lichenoid in appearance, but the diseases are distinct from psoriasis, lichen planus, or other recognized dermatoses. Proposed nomenclature divides parapsoriasis into two distinct subgroups, PITYRIASIS LICHENOIDES and parapsoriasis en plaques (small- and large-plaque parapsoriasis).
Lichen Planus
An inflammatory, pruritic disease of the skin and mucous membranes, which can be either generalized or localized. It is characterized by distinctive purplish, flat-topped papules having a predilection for the trunk and flexor surfaces. The lesions may be discrete or coalesce to form plaques. Histologically, there is a "saw-tooth" pattern of epidermal hyperplasia and vacuolar alteration of the basal layer of the epidermis along with an intense upper dermal inflammatory infiltrate composed predominantly of T-cells. Etiology is unknown.
Clinical Trials
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This is a research study whose purpose is to test the effectiveness of etanercept (Enbrel) in the treatment of moderate to severe lichen planus. No studies have been done on the effective...
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Safety and Effectiveness of Efalizumab to Treat Oral Lichen Planus
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PubMed Articles
A study on the association with hepatitis B and hepatitis C in 1557 patients with lichen planus.
Abstract Background Previous reports have demonstrated contradicting results on the association between lichen planus and hepatitis. Objectives The aim of this study was to investigate the association...
Objective:We report an extremely rare case of laryngeal lichen planus.Method:A case report and literature review of the aetiopathogenesis, clinical features and management of laryngeal lichen planus a...
Lichen planus is a chronic mucocutaneous T-cell-mediated disease, whose cause is still unknown. The first case of lichen planus that transformed into squamous cell carcinoma was reported in 1903. We p...
Vulvar lichen sclerosus and lichen planus are T-cell-mediated chronic skin disorders. Although autoimmunity has been suggested, the exact pathogenesis of these disorders is still unknown. Therefore, t...
Premalignant nature of oral and vulval lichen planus: Facts and controversies.
Although many classifications include oral lesions of lichen planus in the category of a premalignant condition, there is still much discussion about whether the mucous membranes lesions should be cha...
