A Randomized Controlled Trial Comparing Healing Outcomes of Intralesional Glucantime With and Without Fractional CO₂ Laser in Adults With Cutaneous Leishmaniasis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete clinical cure
研究概览
简要总结
Cutaneous leishmaniasis is a common parasitic skin disease causing chronic ulcerative lesions and scarring. Intralesional meglumine antimoniate (Glucantime) is a widely used treatment; however, healing may be prolonged and cosmetic outcomes may be suboptimal. Fractional CO₂ laser therapy may enhance drug penetration, accelerate healing, and improve cosmetic results. This randomized controlled trial aims to compare the healing outcomes of intralesional Glucantime alone versus intralesional Glucantime combined with fractional CO₂ laser therapy in adult patients with cutaneous leishmaniasis treated at CMH Peshawar. A total of 150 participants will be randomized in a 1:1 ratio and followed for assessment of clinical healing, lesion size reduction, cosmetic outcomes, and adverse events.
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)
盲法说明
Clinical outcomes will be assessed by an independent blinded evaluator using standardized digital photographs. The evaluator will be unaware of treatment allocation to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤60 years.
- •Clinically diagnosed and/or smear-confirmed cutaneous leishmaniasis.
- •Presence of at least one measurable cutaneous lesion suitable for treatment.
- •Willing and able to provide written informed consent.
- •Willing to undergo study treatment and comply with scheduled follow-up visits.
排除标准
- •Previous treatment for the current lesion(s).
- •Mucocutaneous or visceral leishmaniasis.
- •Pregnancy or lactation.
- •Severe systemic illness or immunosuppression.
- •Known hypersensitivity or contraindication to study interventions.
- •Lesions located within 2 cm of the eyelid margin or mucosal lip (laser safety concern).
- •Inability or unwillingness to comply with study procedures or follow-up.
研究组 & 干预措施
Intralesional Glucantime + Fractional CO₂ Laser
Participants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis.
干预措施: Fractional CO₂ laser (Procedure)
Intralesional Glucantime Alone
Participants will receive intralesional meglumine antimoniate (Glucantime) according to the study protocol for the treatment of cutaneous leishmaniasis.
干预措施: Meglumine Antimoniate (Drug)
Intralesional Glucantime + Fractional CO₂ Laser
Participants will receive intralesional meglumine antimoniate (Glucantime) combined with fractional CO₂ laser therapy according to the study protocol for the treatment of cutaneous leishmaniasis.
干预措施: Meglumine Antimoniate (Drug)
结局指标
主要结局
Complete clinical cure
时间窗: 12 weeks
Clinical Cure: Complete re-epithelialization of lesion with absence of induration.
次要结局
- Time-to-healing Adverse events.(12 weeks)
研究者
Kaleem Ullah
Post graduate resident
Combined military hospital Peshawar