Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment

June 18, 2026 updated by: Noor Aziz

Comparative Efficacy of Clobetasol 0.05% Versus Intralesional Triamcinolone in Treatment of Hypertrophic Lichen Planus at a Tertiary Care Hospital

The purpose of this study is to compare the efficacy and safety of two standard corticosteroid treatments for hypertrophic lichen planus (HLP), a chronic inflammatory skin condition that causes thick, intensely itchy plaques.

Patients participating in the study will be randomly assigned to one of two treatment groups:

  • Group A will apply a superpotent topical steroid cream (Clobetasol propionate 0.05%) to their lesions twice daily for 12 weeks.
  • Group B will receive intralesional injections of a steroid medication (Triamcinolone acetonide 10 mg/mL) directly into the lesions once every 4 weeks for a total of four sessions over 12 weeks.

The primary objective is to determine which approach achieves a better reduction in plaque thickness and severity using the Lichen Planus Severity Index (LPSI) score at week 12. The study will also track changes in itching severity using a Visual Analog Scale (VAS), changes in overall lesion surface area, and monitor for any local side effects such as skin thinning or pigment changes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, single-blind (outcome assessor blinded), parallel-group clinical trial conducted at the Department of Dermatology, Combined Military Hospital, Abbottabad, Pakistan. A total of 116 eligible participants (58 per group) aged 18 and older with a confirmed diagnosis of hypertrophic lichen planus will be enrolled via consecutive sampling. Group A will receive topical Clobetasol propionate 0.05% cream twice daily for 12 weeks. Group B will receive intralesional Triamcinolone acetonide (10 mg/mL, 0.1-0.2 mL per site spaced 1 cm apart, max 0.5 mL/cm²) at weeks 0, 4, 8, and 12. Outcome parameters (LPSI, pruritus VAS, and lesion area in cm²) will be recorded at baseline, week 4, week 8, and week 12 to statistically evaluate and compare clinical response rates and the incidence of adverse drug reactions between the two treatment modalities.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhua
      • Abbottabad, Khyber Pakhtunkhua, Pakistan, 21200
        • Department of Dermatology, Combined Military Hospital (CMH)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >= 18 years, both genders[cite: 1]
  • Confirmed clinically as hypertrophic lichen planus with Lichen Planus Severity Index (LPSI) score >= 2 at baseline and Pruritus Visual Analog Scale (VAS) score >= 4 at baseline[cite: 1]
  • No use of topical or intralesional treatment of lichen planus within the last 4 weeks[cite: 1]
  • Able to provide written informed consent in English or Urdu language[cite: 1]

Exclusion Criteria:

  • Drug-induced lichenoid lesions[cite: 1]
  • Pregnant or lactating women[cite: 1]
  • Uncontrolled diabetes mellitus or any other active skin infections[cite: 1]
  • Necessity of systemic corticosteroids or immunosuppressive drugs as the primary treatment[cite: 1]
  • Previous history of hypersensitivity or sensitivity to the study medicines (clobetasol propionate or triamcinolone acetonide)[cite: 1]
  • Refusal to provide informed consent[cite: 1]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topical Clobetasol Propionate
Subjects will apply superpotent topical clobetasol propionate 0.05% cream in a thin film to the affected lesion twice daily (morning and night) for a total duration of 12 weeks
Drug: Clobetasol propionate 0.05% cream
Superpotent topical corticosteroid cream applied twice daily for 12 weeks (p. 4). Patients are instructed to avoid washing the area for 30 minutes after application
Active Comparator: Intralesional Triamcinolone Acetonide
Subjects will receive 10 mg/mL of triamcinolone acetonide injected intralesionally using a 26-gauge needle. The dose will be 0.1-0.2 mL per site separated by 1 cm, with a maximum volume of 0.5 mL/cm² of lesion size. Injections will be given during weeks 0, 4, 8, and 12 (total of 4 sessions over 12 weeks) (p. 4). Topical lidocaine 2% gel will be applied 5 minutes before injection for local anesthesia
Drug: Triamcinolone acetonide 10 mg/mL injection
Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 12 weeks
The Lichen Planus Severity Index (LPSI) is a clinical scoring system used to evaluate the severity of hypertrophic lichen planus lesions based on physical characteristics (such as plaque thickness, elevation, and hyperkeratosis). The score ranges from 0 to 4, where a score of 0 indicates complete flattening/resolution of plaques, and higher scores represent increased lesion severity. Clinical response at 12 weeks will be categorized based on the reduction from baseline: Complete Response (LPSI = 0), Good Response (>= 2-point reduction), Partial Response (1-point reduction), and No Response (no reduction or worsening).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noor Aziz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 18, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Derma Cmh Abbottabad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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