跳至主要内容
临床试验/CTRI/2025/11/097645
CTRI/2025/11/097645尚未招募不适用

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

Sanjeevani Gupta1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月22日最近更新:

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

发起方
Sanjeevani Gupta
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Sanjeevani Gupta

Jawaharlal Nehru Medical College , Datta Meghe Institute Of Higher Education And Research

研究点 (1)

Loading locations...

相似试验