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To compare the effectiveness of topical Roflumilasr 0.3 percent and topical Triamcinolone 0.1 percent in Oral Lichen Planus patients.

Comparative effectiveness of topical Roflumilast 0.3 percent vs Triamcinolone acetonide 0.1 percent in symptomatic Oral Lichen Planus patients: a randomized controlled trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080456
Enrollment
32
Registered
2025-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: L439- Lichen planus, unspecified

Interventions

Intervention1: Topical Roflumilast 0.3%: Topical application of Roflumilast 0.3% in symptomatic Oral Lichen Planus patients with followup on baseline, 1,2 and 3 months. Control Intervention1: Topical

Sponsors

KRITIKA TIWARI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants of both gender and age between 18 years to 60 years, will be diagnosed with symptomatic lesions of reticular, atrophic, and erosive oral lichen planus based on clinical, histopathological criteria by WHO. Patients who give informed consent after explaining the treatment type will be included in the study.

Exclusion criteria

Exclusion criteria: Patients with any other Potentially Malignant Oral Disorders (PMOD) will be excluded. Pregnant females and breastfeeding mothers will be excluded. Patients with a history of corticosteroids, NSAIDs, or any other treatment in the last 30 days will be excluded. Treatment with any drug or restoration that may include lichenoid reaction. Patients with other systemic diseases or illnesses will be excluded. Patient allergic to stated medication will also be excluded

Design outcomes

Primary

MeasureTime frame
appearance of normal mucosa (Score 2 on Thongprasom scale),pain and Burning sensation (VAS 3).Timepoint: Baseline, 1 month, 2 months, 3 months

Secondary

MeasureTime frame
normal mucosa (Score 0),absence of pain and BS (VAS 0)Timepoint: Baseline, 1 month, 2 months, 3 months

Countries

India

Contacts

Public ContactDr Adit

Institute of Medical Sciences, Banaras Hindu University

adit@bhu.ac.in9451525522

Outcome results

None listed

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