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| Sponsor: | Centre Hospitalier Universitaire de Nice |
|---|---|
| Information provided by: | Centre Hospitalier Universitaire de Nice |
| ClinicalTrials.gov Identifier: | NCT00321750 |
Purpose
Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms. The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a theoretical interest in treating OELP: this has been emphasized by several open studies performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative study which confirmed the potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus through human mucosa is still unknown. Its application on ulcerative lesions such as OELP ones, could lead to significant systemic levels of the molecule.
Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus (OELP) and to assess its tolerance.
| Condition | Intervention | Phase |
|---|---|---|
|
Oral Erosive Lichen Planus |
Drug: 1% pimecrolimus cream |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 2 Study of the Treatment of Oral Erosive Lichen Planus With 1% Pimecrolimus Cream: a Double Blind Randomized Prospective Trial With Measurement of Pimecrolimus Levels in the Blood |
| Estimated Enrollment: | 14 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | April 2005 |
Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms. The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a theoretical interest in treating OELP: this has been emphasized by several open studies performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative study which confirmed the potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus through human mucosa is still unknown. Its application on ulcerative lesions such as OELP ones, could lead to significant systemic levels of the molecule.
Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus (OELP) and to assess its tolerance.
Design: Double blind randomized trial with placebo control.
Settings: Outpatients of the Department of Dermatology of the University hospital of Nice, France.
Patients: Fourteen consecutive patients with OELP confirmed by histological examination and with a clinical score superior to 3. 1% pimecrolimus cream or its vehicle were applied on ulcerated lesions twice a day for 4 weeks.
Main outcome measures; the efficacy of the treatment was quantified using a 12 points clinical score. Blood level of pimecrolimus was analyzed at D0, D14 and D28.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Thierry D Passeron, MD | CHU de Nice |
| Study Director: | Jean-Philippe Lacour, MD | CHU de Nice |
| Study Chair: | Jean-Paul Ortonne, MD | CHU de Nice |
| Study Chair: | Eric Fontas, MD | CHU de Nice |
More Information
| Study ID Numbers: | CASM981CFR01 |
| Study First Received: | May 2, 2006 |
| Last Updated: | October 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00321750 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Oral erosive lichen planus pimecrolimus cream |
|
Anti-Inflammatory Agents Lichen Planus Immunologic Factors Skin Diseases Physiological Effects of Drugs Pimecrolimus Tacrolimus Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Lichenoid Eruptions Central Nervous System Agents Dermatologic Agents Skin Diseases, Papulosquamous |
