Comparative Efficacy of Clobetasol 0.05% Versus Intralesional Triamcinolone in Treatment of Hypertrophic Lichen Planus at a Tertiary Care Hospital
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •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]
研究者
Noor Aziz
Post Graduate Resident
Combined Military Hospital Abbottabad