Health Condition 1: L438- Other lichen planus
Conditions
Interventions
Intervention1: Apremilast: Day 1: 10mg AM Day 2: 10mg AM, 10 mg PM Day 3: 10mg AM, 20 mg PM Day 4: 20mg AM, 20 mg PM Day 5: 20mg AM, 30 mg PM Day 6: 30mg AM, 30 mg PM 30mg twice a day from day 7 until
Sponsors
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Both male and female patients aged >= 18 years and 2. Patients with history of cutaneous or mucosal lichen planus. 3. Patients with a PGA score of 3 or more. 4. Patients with biopsy/dermoscopy confirmed lichen planus. 5. Patients who are candidates for systemic therapies. 6. Patients who are refractory to treatment with topical corticosteroids. 7. Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with lichen sclerosis et atrophicus (LS&A) 2. Clinical history and lesion distribution suspicious for a lichenoid drug eruption 3. Pregnant or nursing females. 4. Other skin disease that might interfere with lichen planus assessments. 5. Patients with known hypersensitivity to the study drugs. 6. Patients with immunosuppressive disease or on immunosuppressive drugs. 7. Patients with liver dysfunction. 8. Patients with a history of seizures 9. Patients with history of psychiatric disorders. 10. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments. 11. Active severe infections, or prior infection requiring hospitalization or oral/intravenous antibiotics within 4 weeks before screening visit, or between the screening and baseline visits. 12. Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectâ??s ability to safely complete the study. 13. History of drug or alcohol dependency or abuse within approximately the last 2 years. 14. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study. 15. Any patient whom the investigator judged to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoints: Primary end point the study will be the proportion of patients who achieve a significant clinical response in cutaneous disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score after 12 weeks of treatment.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| â??Target areaâ?? is defined as the part of the body with the greatest disease severity; its boundaries are clearly defined and documented at baseline to facilitate future assessments. Change in mean target lesion symptom score â?? erythema Change in mean target lesion symptom score â?? elevation. Change in mean target lesion symptom score â?? pruritus Timepoint: 12 weeks;Safety Proportion of patients discontinuing therapy with apremilast during study period. Proportion of patients experiencing 1 or more adverse events during 12 weeks of treatment. The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal will be summarized by treatment groups Timepoint: 12 weeks;The proportion of patients who achieve a significant clinical response in mucosal disease, defined as a 2-grade or more improvement in the physician global assessment (PGA) score Proportion of patients achieving subject global assessment (SGA) of complete resolution or marked improvement Change in mean target area lesion symptom score from baseline Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Vishalakshi Viswanath
Rajiv Gandhi Medical College and Chhatrapati Shivaji Maharaj Hospital
Outcome results
None listed