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Trial record 14 of 18 for:    Atrophic Lichen Planus

Clinical and Immunohistochemical Effect of Topical Pimecrolimus in Treatment of Oral Lichen Planus

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ClinicalTrials.gov Identifier: NCT02443311
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Ola Mohamed Ezzatt, Ain Shams University

Brief Summary:
Oral lichen planus (OLP) is a chronic disease characterized by periods of remission and relapse. Therapeutic objectives for OLP should be to quickly reduce disease symptoms by targeting pathophysiological pathways, and to provide long-term management by reducing recurrences. Pimecrolimus is a novel topical selective inflammatory cytokine release inhibitor; considering its mechanism of action it is reasonable to theorize that pimecrolimus may effectively treat OLP without the potential side effects that are associated with corticosteroids.

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Pimecrolimus 1% cream Drug: Betamethasone 17-valerate 0.1% cream Phase 4

Detailed Description:
Lichen planus is a chronic, immunological, mucocutaneous disease, characterized by periods of remission and relapse1. Oral lichen planus (OLP) is one of the most common mucocutaneous diseases manifesting in the oral cavity, and the oral mucosa may be the only site of involvement 2, with variable incidence between 0.5% and 4% 3. Three major clinical forms of OLP (reticular, erosive/ ulcerative, and erythematous/atrophic) have been recognized, which could alternate and overlap in a dynamic state as disease progresses. Ulceration is the most severe form that it interferes with eating, speech, and swallowing. Erosive OLP lasts for years, resistance to treatment and spontaneous remissions are rare 4,5. Oral lichen planus is a T-cell-mediated chronic inflammatory oral mucosal disease. Both antigen-specific and non-specific mechanisms may be involved in the pathogenesis of OLP. Antigen-specific mechanisms include antigen presentation by basal keratinocytes to CD4+ helper T-cells that are stimulated to secrete the T helper -1 cytokines IL-2 and IFN-γ. Subsequently, CD8+ cytotoxic T-cells may be activated which then trigger basal keratinocyte apoptosis in OLP. While, non-specific mechanisms include mast cell degranulation and matrix metalloproteinase (MMP) activation in OLP lesions 6. The best known treatment of OLP remains high-potency topical corticosteroids7. However, corticosteroids are known to induce local atrophy, fragility, and telangiectasias, and to promote infections, including acute candidiasis. They also have theoretical risks of lowering local immunity, corticosteroids can exert their effects on the immune system by modulating transcription of genes in cells involved in immune response and other cell types; therefore this mode of action is not selective for the pathogenesis of lichen planus 8-10. A recent Cochrane review showed only little evidence for superiority of the assessed interventions over placebo for palliation of symptomatic OLP and recommended the need of randomized clinical trials on new therapies 11. Pimecrolimus a novel topical selective inflammatory cytokine release inhibitor; that binds to intra-cytoplsmic protein (macrophillin-12) subsequently inhibiting dephosphorylation of nuclear factor of activated T cells by calcineurin; this markedly reduces T-cell cytokine production. Given the T-cell-mediated pathogenesis of OLP, application of this calcineurin inhibitor seems to be a promising therapeutic option 12-14. Several case studies and open-label trials used topical pimecrolimus in treatment of OLP reported beneficial effects 12,15. Few prospective, randomized, vehicle-controlled studies have also been conducted and proved benefit of pimecrolimus over placebo 16,10,17. And one recent prospective study compared the effect of topical pimecrolimus with topical corticosteroid in treatment of OLP 18. The purpose of this study was to compare the effectiveness of topical pimecrolimus 1% with topical corticosteroid, in the treatment of oral erosive and atrophic lichen planus as a prospective, comparative clinical trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparative Clinical and Immunohistochemical Study Between Topical Pimecrolimus and Corticosteroid in Treatment of Oral Lichen Planus
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I
Pimecrolimus 1% cream (Elidel, Novartis Pharmaceuticals, East Hanover, NJ)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks
Drug: Pimecrolimus 1% cream
Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.

Active Comparator: Group II
Betamethasone 17-valerate 0.1% cream (Betnovate, GlaxoSmithKline, Cairo, Egypt)+ custom made hydrophilic Adhesive gel base (Department of Pharmaceutics and Industrial Pharmacy. Faculty of Pharmacy. Ain Shams University) 4 Times/day for 4 weeks
Drug: Betamethasone 17-valerate 0.1% cream
Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.Topical antifungal Miconazole 2% gel (Miconaz, oral Medical Union Pharmaceutical, Cairo, Egypt) was applied only in the fourth week of treatment period to avoid secondary candidiosis




Primary Outcome Measures :
  1. clinical scoring (CS) [ Time Frame: 2 months/ once per week for one months then after 2 months ]
    0 represented no lesion/normal mucosa; 1, mild white striae/no erythematous area; 2, white striae with atrophic area less than 1 cm²; 3, white striae with atrophic area more than 1 cm²; 4, white striae with erosive area less than 1 4 cm²; and 5, white striae with erosive area more than 1 cm²

  2. visual analog scale (VAS) [ Time Frame: 2 months/ once per week for one months then after 2 months ]
    Patients also ranked the severity of pain and burning sensation on 100-mm visual analog scale


Secondary Outcome Measures :
  1. CD4+,CD8+, CD133 [ Time Frame: baseline and after 1 month treatment ]
    Immunohistochemical analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically and histologically confirmed painful Erosive or Atrophic OLP
  • free from any systemic diseases using medical questionnaire guided by Cornell Medical Index

Exclusion Criteria:

  • history of drug induced lichenoid lesions
  • potential treatment of OLP for less than 2 weeks by topical and 4 weeks systemic therapy before study start
  • pregnant or breast-feeding women,
  • smoking and
  • known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
  • loss of paliability or flexibility in the tissues involved by the oral lesions or histological signs of epithelial dysplasia or lichenoid lesions within the biopsied sites.

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Responsible Party: Ola Mohamed Ezzatt, Lecturer of oral medicine and periodontology, Ain Shams University
ClinicalTrials.gov Identifier: NCT02443311     History of Changes
Other Study ID Numbers: FDASU-RECD 1214401
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Pimecrolimus
Betamethasone sodium phosphate
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors