NCT01524744

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

3.6 years

First QC Date

January 31, 2012

Last Update Submit

February 1, 2012

Conditions

Oral Lichen Planus

Keywords

oral lichen planus treatment pimecrolimus

Outcome Measures

Primary Outcomes (1)

  • signs of oral lichen planus

    size and type of oral lichen planus has been recorded

    every 2 weeks

Secondary Outcomes (1)

  • symptoms of oral lichen planus

    every 2 weeks

Study Arms (2)

Pimecrolimus ointment 0.1 %

ACTIVE COMPARATOR

This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use

Drug: Pimecrolimus ointmentDrug: Adcortyl

Adcortyle

ACTIVE COMPARATOR

Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)

Drug: Adcortyl

Interventions

Pimecrolimus ointmentDRUG

Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use

Pimecrolimus ointment 0.1 %
AdcortylDRUG

triamcinolone acetonide 0.1% in orabase

AdcortylePimecrolimus ointment 0.1 %

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad University of Medical Science

Mashhad, Khorasan Razavi, 91735, Iran

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • atessa pakfetrat, associate professor

    Mashhad University of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

March 1, 2009

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

IR(1)