Skip to content

Effectiveness of topical triamcinolone combined with oral apremilast versus topical triamcinolone alone in oral lichen planus

Randomised clinical trial to study the clinical efficacy of oral apremilast with topical triamcinolone acetonide versus topical triamcinolone acetonide alone (standard care) in oral lichen planus.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051002
Enrollment
56
Registered
2023-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L438- Other lichen planus

Interventions

Intervention1: Topical triamcinolone acetonide 0.1% oral paste for local applicarion thrice a day and oral apremilast 30 mg BD: Patients fulfilling the inclusion criteria will be included in the study

Sponsors

All India Institute of Medical Sciences, Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Patients with clinical diagnoses of oral lichen planus or biopsy proven oral lichen planus. b) Age more than 16 years c) Treatment wash off period of 2 weeks for topical drugs and 4 weeks for immunosuppressive drugs.

Exclusion criteria

Exclusion criteria: a) Pregnant and lactating women b) Hypersensitivity to oral apremilast c) Known case of renal and hepatic impairment d) Known case of psychiatric disease e) Patients with extensive cutaneous involvement secondary to lichen planus. f) Patients with dental restoration in situ

Design outcomes

Primary

MeasureTime frame
Change in clinical severity score (CSS)Timepoint: At 3 weeks, 6 weeks, 9 weeks and 12 weeks.

Secondary

MeasureTime frame
Change in pain on visual analog scaleTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 weeks.;Change in patientâ??s quality of life.Timepoint: At 3 weeks, 6 weeks, 9 weeks and 12 weeks.;Change in serum interleukin 6 & 8 (IL-6,IL-8)Timepoint: Baseline, at the end of treatment and in cases of relapse;Patient satisfaction with treatment using percentage gradingTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 weeks.;Side effects of drugTimepoint: At 3 weeks, 6 weeks, 9 weeks and 12 weeks.

Countries

India

Contacts

Public ContactDr Anupama Bains

All India Institute of Medical Sciences, Jodhpur

doc.trinity@yahoo.com7297895727

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026