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
Study Sites (1)
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