A Phase 2 interventional study of Pimecrolimus 1% cream in Oral Lichen Planus, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-17.
Sponsored by University of Utah · Phase 2, Interventional, and Treatment
Study investigating the use of pimecrolimus 1% cream for oral lichen planus
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 pimecrolimus 1% cream when applied twice daily with occlusion in the treatment of oral lichen planus.
139 studies on the registry are indexed under Lichen Planus, Oral; 24 are open to participants now.
This study's enrollment of 21 is below the median of 36 across 101 interventional studies indexed under Lichen Planus, Oral.
Browse Lichen Planus, Oral studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
Drug: Pimecrolimus 1% cream
"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
Drug: Pimecrolimus 1% cream
pimecrolimus cream or matching placebo BID for 6 weeks
Also known as: elidel cream
The Primary Efficacy Variable Was the Change in the Investigator's Global Assessment of the Overall Severity of Disease From Baseline to Week 6.
The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. 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).
Time frame: 0, 1, 2, 4, 6 weeks
The Secondary Efficacy Variables Was Changes Erythema and Assessment of Spontaneous Pain on a Visual Analog Scale (0-10).
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).
Time frame: 0, 1, 2, 4, 6 weeks
The Secondary Efficacy Variable Was Change in the Size of a Target Erosion in Millimeters.
Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.
Time frame: 0, 1, 2, 4, 6 weeks
| Milestone | Pimecrolimus 1% Cream | Vehicle Cream |
|---|---|---|
| Started | 10 | 11 |
| Completed | 8 | 11 |
| Not completed | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
The primary efficacy variable was the change in the Investigator's Global Assessment of the overall severity of disease from baseline to week 6. Scale is 0-4. 0 is no disease. 4 is worst disease. Minimum score is 0. Maximum score is 4. 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).
| units on a scale | Pimecrolimus Cream | Vehicle Cream |
|---|---|---|
| baseline | 2.4 (2 to 4) | 2.45 (1 to 3) |
| week 6 | 1.6 (0 to 2) | 2.27 (1 to 4) |
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).
| units on a scale | Pimecrolimus Cream | Vehicle Cream |
|---|---|---|
| mean erythema baseline | 2 (0 to 3) | 2 (0 to 3) |
| mean erythema week 6 | 1 (0 to 2) | 1 (0 to 2) |
| mean pain baseline | 3 (0 to 7) | 4 (0 to 8) |
| mean pain week 6 | 2 (0 to 5) | 3 (0 to 8) |
Secondary outcome variable was change in size of the target erosion in millimeters from baseline compared to week 6.
| mm | Pimecrolimus Cream | Vehicle |
|---|---|---|
| mean erosion baseline | 11 (1 to 25) | 33 (4 to 120) |
| mean erosion week 6 | 4 (0 to 18) | 21 (0 to 120) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimecrolimus 1% Cream | — | 0/10 (0%) | 5/10 (50%) |
| Vehicle Cream | — | 0/11 (0%) | 7/11 (63.6%) |
| Event | Pimecrolimus 1% Cream | Vehicle Cream |
|---|---|---|
| upper respiratory infectionInfections and infestations | 4/10 | 4/11 |
| leg fractureMusculoskeletal and connective tissue disorders | 1/10 | 0/11 |
| blister on gumSkin and subcutaneous tissue disorders | 0/10 | 1/11 |
| cold sore on lipSkin and subcutaneous tissue disorders | 0/10 | 1/11 |
| flu-like illnessGastrointestinal disorders | 0/10 | 1/11 |
| Age, Categorical(Participants) | Pimecrolimus 1% Cream | Vehicle Cream | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 9 | 19 |
| >=65 years | 0 | 2 | 2 |
| Sex: Female, Male(Participants) | Pimecrolimus 1% Cream | Vehicle Cream | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 2 | 3 | 5 |
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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