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NCT Number: NCT07666620

Efficacy of Clobetasol Vs Intralesional Triamcinolone in Lichen Planus Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Dermatology, Combined Military Hospital (CMH)

Abbottabad, Khyber Pakhtunkhua, 21200, Pakistan

Location contact

Noor Aziz, MBBS, POST GRADUATE FELLOW

CONTACT

[email protected]

+9233361571005

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

Clobetasol Propionate 0.05% Cream

Drug

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

Triamcinolone acetonide 10 mg/mL injection

Drug

Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Noor Aziz

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.