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Clinical Trials/CTRI/2024/02/063136
CTRI/2024/02/063136Not yet recruitingPhase 2

Comparison of the Efficacy of Photodynamic Therapy (Methylene blue using Soft Tissue Diode LASER) with Topical Tacrolimus in the Management of patients with Oral Lichen planus- Two arm double blinded clinical trial.

Dr Aparna Raj1 site in 1 country25 target enrollmentStarted: February 3, 2024Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Independent variables- Tacrolimus, Photodynamic therapy

Study Overview

Brief Summary

This study is the Two arm concurrent parallel experimental study Comparing of the efficacy of Photodynamic Therapy(Methylene blue using soft tissue diode LASER)with Topical Tacrolimus in the management of patients with Oral Lichen Planus.

It is the study for post-graduation Main dissertation/thesis and will be done in the institution in the Department of Oral Medicine and Radiology of PCDS, Bhopal,M.P.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Double Blind Double Dummy

Eligibility Criteria

Ages
15.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •clinically and histopathologically cofirmed cases of lichen planus, patients who have cleared the patch test for tacrollimus participants wiiling to be part of the study and have signed informed consent.

Exclusion Criteria

  • •patients having other autoimmune disorders.
  • •patients who are already under going gtreatment for lichen planus.
  • •pregnant and lactating women.
  • •patient with allergies to methyllene blue,tacrollimus,LASERS.

Outcomes

Primary Outcomes

Independent variables- Tacrolimus, Photodynamic therapy

Time Frame: 8 weeks

Dependent variables-burning sensation,pain,size of lesion

Time Frame: 8 weeks

Secondary Outcomes

  • Dependent variables - Dependent variable-Burning sensation, pain, size of the lesion(Independent variables- Tacrolimus, Photodynamic therapy)

Investigators

Sponsor
Dr Aparna Raj
Sponsor Class
Other [self]

Study Sites (1)

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