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Comparison of Two Topical Medicines (Halobetasol and Tacrolimus) in the management of Cutaneous Lichen Planus

COMPARATIVE STUDY OF HALOBETASOL 0.05% VS TACROLIMUS 0.1% IN THE TREATMENT OF CUTANEOUS LICHEN PLANUS- A RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102449
Enrollment
108
Registered
2026-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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: HALOBETASOL 0.05 % VS TACROLIMUS 0.1%: HALOBETASOL 0.05 % MORNING FOR 4 WEEKS TACROLIMUS 0.1% FOR MORNING AND NIGHT FOR 4 WEEKS Control Intervention1: HALOBETASOL 0.05% VS TACROLIMUS

Sponsors

DR AKSHAY VILASRAO PATIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects Who were diagnosed clinically and Histopathologically with lichen planus lesions Subjects who have not been on any form of therapy for atleast a month prior to their enrolment

Exclusion criteria

Exclusion criteria: Childern less than 12 years of age

Design outcomes

Primary

MeasureTime frame
Change in severity of cutaneous lichen planus lesions Assessed by reduction in validated Lichen Planus Severity Index (LPSI / LPASI) Measured from baseline to end of treatment (e.g., 8 or 12 weeks) TO compare efficacy of Halobetasol vs Tacrolimus.Timepoint: Change in severity of cutaneous lichen planus lesions Assessed by reduction in validated Lichen Planus Severity Index (LPSI / LPASI) Measured from baseline to end of treatment (e.g., 8 or 12 weeks) TO compare efficacy of Halobetasol vs Tacrolimus.

Secondary

MeasureTime frame
Reduction in pruritus (itching) score Measured using Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) Percentage of patients achieving complete or near-complete clinical clearance Based on physician global assessmentTimepoint: At baseline , 4 weeks , 8 weeks using visual analogue scale

Countries

India

Contacts

Public ContactDRCABHIRAMI

VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL KARAIKAL

abhiramisundari87@gmail.com9944118397

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026