The Value of Adding Mini-oral Pulse Steroid Therapy in Preventing Peri-lesional Halo Post Non-cultured Epidermal Cell Suspension (NCES) in Cases With Stable Segmental and Non-acral Vitiligo: An Interventional Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of perilesional halo
研究概览
简要总结
The goal of this clinical trial is to learn if adding mini-oral pulse steroid therapy improves the results of non-cultured epidermal cell suspension (NCES) surgery in patients with stable vitiligo. It will also evaluate the safety of this treatment approach. The main questions it aims to answer are:
- Does adding mini-oral pulse steroid therapy reduce the development of a perilesional halo after NCES surgery?
- Does the addition of steroids improve the degree of repigmentation and overall treatment outcomes in vitiligo lesions?
Researchers will compare NCES surgery with mini-oral pulse steroids to NCES surgery alone to determine whether the steroid therapy improves surgical outcomes.
Participants will:
- Undergo NCES vitiligo surgery for stable segmental or non-acral vitiligo lesions.
- Be randomly assigned to receive either surgery alone or surgery plus low-dose oral mini-pulse dexamethasone therapy.
- Attend follow-up visits and clinical assessments for approximately 4 months.
- Receive excimer laser sessions twice weekly after healing and have standardized photographs and scoring assessments to evaluate repigmentation.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with segmental vitiligo lesions that are not responsive to conventional treatment.
- •Patients with non-Acral vitiligo lesions that are not responsive to conventional treatment and on sites known to be responsive to surgery, like the face and trunk.
- •Stability for ≥ 1 year.
- •Age ≥12 years.
- •Lack of systemic and topical treatment for at least 3 months prior inclusion in the study.
排除标准
- •Acral vitiligo.
- •Segmental vitiligo lesions that are responsive to conventional treatment.
- •Non acral vitiligo lesions on sites that are knowingly not responsive to surgery, like knees and elbows.
- •Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges, hypochromia, depigmentation of previously pigmented areas or koebnerization in < 1 year.
- •Age < 12 years.
- •Pregnant females.
- •Patients with contraindication to systemic steroid like uncontrolled hypertension, diabetes or tuberculosis
- •Systemic and topical treatment in the past 3 months.
研究组 & 干预措施
Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy
Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety.
干预措施: Non-cultured epidermal cell suspension (NCES) surgery (Procedure)
Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy
Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety.
干预措施: Oral mini pulse (Drug)
Non-cultured epidermal cell suspension surgery with Mini-Oral Pulse Steroid Therapy
Participants will receive low-dose oral mini-pulse dexamethasone (5 mg/week given on two consecutive days) for 4 weeks before and 4 weeks after undergoing non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to assess repigmentation, development of perilesional halo, and treatment safety.
干预措施: Excimer Sessions (Device)
Non-cultured epidermal cell suspension Surgery Alone
Participants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo.
干预措施: Non-cultured epidermal cell suspension (NCES) surgery (Procedure)
Non-cultured epidermal cell suspension Surgery Alone
Participants will undergo non-cultured epidermal cell suspension (NCES) surgery for stable vitiligo lesions without oral mini-pulse steroid therapy. After healing, participants will receive excimer laser sessions twice weekly and will be followed for 4 months to evaluate repigmentation outcomes and development of perilesional halo.
干预措施: Excimer Sessions (Device)
结局指标
主要结局
Incidence of perilesional halo
时间窗: 4 months
• Comparing the incidence of perilesional halo after 4 months of treatment with NCES with and without OMP.
Percent change in VESTA score
时间窗: 4 months
Comparing percent change in pigmentation as per VESTA score with and without OMP.
Percent change in the surface area of the depigmented patch using point counting technique
时间窗: 4 months
Comparing percent change in the surface area of the depigmented patch following NCES using point counting technique with and without OMP
次要结局
- Comparing physician global assessment between two groups(4 months)
- Assessing tolerability and safety of oral mini-pulse(4 months)
- Assessing change in visual analogue scale(4 months)
- Compare VESTA percentage change in different body sites and age groups(4 months)
研究者
Lobna Gamal Alieldin
Lecturer
Cairo University