Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream

NCT00321750 | Terminated Phase 2

• 1 other identifier: CASM981CFR01
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Oral Erosive Lichen Planus

Keywords

Oral erosive lichen planus; pimecrolimus cream

Outcome Measures

Primary Outcomes (2)

• The efficacy of the treatment was quantified using a 12 points clinical score.

• Blood level of pimecrolimus was analyzed at D0, D14 and D28.

Secondary Outcomes (2)

• Side effects

• Complete blood count

Interventions

1% pimecrolimus cream DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of the diagnosis of OELP by histological examination and a clinical score superior to 3

You may not qualify if:

• Patients under 18 years
• Pregnancy or breast feeding
• Malignancy
• Severe or recurrent infections
• Uncontrolled chronic disorders
• Congenital or acquired immunosuppression and concomitant treatments potentially effective on OELP such as antimalarials, oral retinoids, steroids or immunosuppressive drugs

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Related Publications (1)

• Passeron T, Lacour JP, Fontas E, Ortonne JP. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol. 2007 Apr;143(4):472-6. doi: 10.1001/archderm.143.4.472.

  PMID: 17438179 DERIVED

MeSH Terms

Interventions

pimecrolimus

Study Officials

• Thierry D Passeron, MD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

• Jean-Philippe Lacour, MD

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

• Jean-Paul Ortonne, MD

  Centre Hospitalier Universitaire de Nice

  STUDY CHAIR

• Eric Fontas, MD

  Centre Hospitalier Universitaire de Nice

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 2, 2006
• First Posted: May 4, 2006
• Study Start: December 1, 2004
• Study Completion: April 1, 2005
• Last Updated: October 18, 2006

Record last verified: 2006-05