A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus

Oral Lichen Planus Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01524744
• Other study ID #: 87909
• Secondary ID: 87909
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: January 31, 2012
• Last updated: February 1, 2012
• Start date: March 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2012
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.

Exclusion Criteria:

• Unable to undergo oral biopsy for diagnosis

• Systemic diseases or malignancy

• Pregnancy

• Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.

• Lesions adjacent to amalgam filling were also excluded from this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Pimecrolimus ointment
Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
• Adcortyl
triamcinolone acetonide 0.1% in orabase

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Science	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	signs of oral lichen planus	size and type of oral lichen planus has been recorded	every 2 weeks	Yes
Secondary	symptoms of oral lichen planus	pain of oral lesions has been recorded	every 2 weeks	Yes