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

NCT02443311 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RECD 1214401
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (2)

• clinical scoring (CS)

  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 months/ once per week for one months then after 2 months

• visual analog scale (VAS)

  Patients also ranked the severity of pain and burning sensation on 100-mm visual analog scale

  2 months/ once per week for one months then after 2 months

Secondary Outcomes (1)

• CD4+,CD8+, CD133

  baseline and after 1 month treatment

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II

ACTIVE COMPARATOR

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

Interventions

Pimecrolimus 1% cream DRUG

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.

Group I

Betamethasone 17-valerate 0.1% cream DRUG

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

Group II

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

pimecrolimus; Betamethasone Valerate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of oral medicine and periodontology

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: May 13, 2015
• Study Start: September 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 13, 2015

Record last verified: 2015-05