Health Condition 1: K137- Other and unspecified lesions of oral mucosa
Conditions
Interventions
Intervention1: Tab Apremilast 30mg: Apremilast 30 mg orally twice daily for 12 weeks.
Control Intervention1: Intralesional triamcinolone acetonide injections
: Intralesional triamcinolone acetonide in
Sponsors
All India Institute of Medical Sciences, Patna
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged more than 18 years. Clinically and histopathologically confirmed oral lichen planus. Recalcitrant disease with inadequate response to at least 8 weeks of standard therapy or relapse after tapering. Symptomatic erosive or atrophic lesions requiring active treatment. Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Lichenoid drug reactions or contact hypersensitivity lesions History or presence of oral epithelial dysplasia or malignancy. Prior treatment with apremilast or intralesional triamcinolone within the past 3 months. Use of systemic immunosuppressive or biologic therapy within 4 weeks prior to enrollment. Severe psychiatric illness, including depression (given known neuropsychiatric effects of apremilast). Pregnancy or lactation. Severe renal impairment or any contraindication to study medications. Known hypersensitivity to apremilast or corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Physician Global Assessment (PGA) score.Timepoint: Intervention: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Subject Global Assessment (SGA)Timepoint: Intervention: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week;Target Area Lesion Symptom Score (TALSS)Timepoint: Intervention: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week;Visual Analog Scale (VAS) for pain and burning sensationTimepoint: Intervention: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week;Oral Health Impact Profile-14 (OHIP-14)Timepoint: Intervention: Baseline,12 weeks,20 weeks ;Adverse eventsTimepoint: Intervention: Baseline,4 weeks,8 weeks,12 weeks,16 weeks,20 weeks Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week;Recurrence or relapse ratesTimepoint: Intervention:16 weeks,20 weeks Comparator: 4 week, 8 week;Injection Site Assessment (pain, ulceration, atrophyTimepoint: Comparator: Baseline,1 week, 2 week, 3 week, 4 week, 8 week | — |
Countries
India
Contacts
Public ContactDr Somansh GOYAL
All India Institute of Medical Sciences, Patna
Outcome results
None listed