Hypertrophic Lichen Planus
Conditions
Keywords
Clobetasol propionate, Triamcinolone acetonide, Intralesional injection, Topical corticosteroid, Lichenoid dermatosis, Hypertrophic skin lesions
Brief summary
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.
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.
Interventions
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
DRUGTriamcinolone acetonide 10 mg/mL injection
Corticosteroid suspension injected directly into the lesions (intralesional) at weeks 0, 4, 8, and 12
Sponsors
Noor Aziz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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\[cite: 1\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | 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). |
Countries
Pakistan
Outcome results
None listed