Clinical Trial: Pimecrolimus Cream for Oral Lichen Planus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 6-week Randomized, Double-blind, Vehicle-controlled Pilot Study With a 6-week Open Label Extension to Assess the Efficacy and Safety of Pimecrolimus 1% Cream in the Treatment of Lichen planus (LP) is an idiopathic inflammatory dermatosis of the skin and mucous membranes. Cutaneous lesions present as pink polygonal papules on the flexor wrists, trunk, thighs, shin and the dorsal hands. Oral lichen planus (OLP) represents a unique subset of LP and is often the sole manifestation of this disease. Clinically, the lesions can be reticulate, erythematous, atrophic or erosive, with the erosive form being the most common. Lesions can be found anywhere in the oral mucosa and are associated with burning pain which is worsened while eating. The risk of development of squamous cell carcinoma has been estimated to be as high as 5%. Treatments for oral lichen planus involve high potency topical steroid, systemic steroids, oral/topical retinoids and immunosuppressants. However, the long term side effects of steroids (e.g. striae, skin atrophy, telangiectasias, tachyphylaxis, secondary candidiasis and perioral dermatitis) prevent more extensive utilization except in the most severe cases. Given the debilitating nature of OLP, risk of malignant transformation, and long term side effects associated with current therapies, a safe intervention is needed for this disorder.

Tacrolimus and pimecrolimus may have fewer side affects than topical steroids. Recently, in an open label trial of 19 patients with recalcitrant erosive lichen planus, tacrolimus decreased the area of ulceration by 73% after an eight week course. Local irritation was the most common side effect. However, tacrolimus comes in an ointment base, a poorly tolerated vehicle for oral lesions. Topical treatment of oral lesions has also been compromised by problems with maintaining sufficient contact time between poorly adherent cream and ointment preparations and moist mucous membrane surfaces.

This study is designed to evaluate the topical application of p
Sponsor: University of Utah

Current Primary Outcome: The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6. [ Time Frame: 0, 1, 2, 4, 6 weeks ]

Original Primary Outcome: The primary efficacy variable will be change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6.

Current Secondary Outcome:

• The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10). [ Time Frame: 0, 1, 2, 4, 6 weeks ]
  The secondary efficacy variables were change in the size of the target erosion, erythema and assessment of spontaneous pain on a visual analog scale (0-10). The scale used to measure erythema is 0-3. 0 is no erythema, 1 is mild erythema, 2 is moderate erythema, and 3 is severe erythema. Minimum score is 0. Maximum score is 3. Spontaneous pain was scored on a scale of 0-10 (0 no pain, 10 severe pain). Measurments were completed day 0, week 1, week 2, week 4, and week 6. Scores are listed at baseline (day 0) and end of study (week 6).
• The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters. [ Time Frame: 0, 1, 2, 4, 6 weeks ]
  Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.

Original Secondary Outcome: The secondary efficacy variables will be changes in the size of the target erosion in millimeters, erythema and assessment of spontaneous pain on a visual analog scale (0-10).

Information By: University of Utah

Dates:
Date Received: February 23, 2006
Date Started: August 2005
Date Completion:
Last Updated: September 14, 2012
Last Verified: June 2012