A comparative study to determine the efficacy of topical Pirfenidone with Carbon dioxide laser versus Emollient with Carbon dioxide laser in the management of keloid
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in keloid size , symptomatic relief and scar appearance
研究概览
简要总结
RESEARCH QUESTION:
Can topical Pirfenidone enhance the therapeutic outcomes of carbon dioxide laser treatment
in patients with keloids more effectively than standard emollient care with carbon dioxide
laser ?
AIMS AND OBJECTIVE:
• To evaluate the efficacy of topical Pirfenidone with CO2 laser therapy in keloid
• To evaluate the efficacy of emollient with CO2 laser therapy in keloids
• To compare the efficacy of efficacy of topical Pirfenidone with carbon dioxide laser vs
emollient with CO2 laser therapy in keloids
• To assess changes in scar characteristics using Detroit keloid scale
STUDY DESIGN:
Randomised Interventional Study
PLACE OF STUDY:
Outpatient department of Dermatology, Venereology & Leprosy, Acharya
Vinoba Bhave Rural Hospital**,**Sawangi Wardha
STUDY POPULATION:
Patients having keloid including both genders and >18 years of age, visiting to the department
of Dermatology, Venerology and Leprosy (DVL),Acharya Vinoba Bhave Rural Hospital,
Sawangi will be included in the study.
INCLUSION CRITERIA:
• Individuals aged more than 18 years
• Patients with clinically diagnosed keloid scars (confirmed by history and examination).
• Willingness to avoid other scar treatments during the study period.
• Ability to give written informed consent.
EXCLUSION CRITERIA:
• Active infection or ulceration over or around the keloid site
• History of keloid treatment within the past 3 months (e.g., steroid injections, laser,
cryotherapy).
• Patients on systemic steroids, immunosuppressants, or anticoagulants.
• Pregnant or lactating women.
• Known hypersensitivity or allergy to pirfenidone or laser procedures.
• History of hypertrophic scars (not true keloids) or other dermatological conditions
mimicking keloids.
• Patient with systemic diseases affecting wound healing (e.g., uncontrolled diabetes,
autoimmune disease).
• Patients with unrealistic expectations
• HIV, Hepatitis C, Hepatitis B positive patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals aged more than 18 years Patients with clinically diagnosed keloid scars confirmed by history and examination Willingness to avoid other scar treatments during the study period Ability to give written informed consent.
排除标准
- •Active infection or ulceration over or around the keloid site History of keloid treatment within the past 3 months eg steroid injections, laser, cryotherapy Patients on systemic steroids, immunosuppressants, or anticoagulants Pregnant or lactating women Known hypersensitivity or allergy to pirfenidone or laser procedures.
- •History of hypertrophic scars or other dermatological conditions mimicking keloids.
- •Patient with systemic diseases affecting wound healing uncontrolled diabetes, autoimmune disease Patients with unrealistic expectations HIV, Hepatitis C, Hepatitis B positive patients.
结局指标
主要结局
Reduction in keloid size , symptomatic relief and scar appearance
时间窗: assessment after 4 weeks , 8 weeks . 12 weeks , 16 weeks , 20 weeks
次要结局
未报告次要终点
研究者
Sanjeevani Gupta
Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research
