跳至主要内容
临床试验/CTRI/2025/12/099153
CTRI/2025/12/099153尚未招募不适用

Comparison of fractional carbon dioxide laser with autologous platelet rich plasma application versus fractional carbon dioxide laser with exosomes application in management of atrophic post acne scars a split face study

MADADI PRGNYA1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月23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
20
试验地点
1
主要终点
Goodman and Baron qualitative and quantitative scores will be used to assess the improvement in Acne scar during and post treatment.

研究概览

简要总结

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients (18-65 years old) Diagnosed with atrophic acne scars Associated pigmentation Fitzpatrick skin types I-IV Able to provide informed consent.

排除标准

  • Active skin infections or open wounds on the face History of autoimmune disease or significant dermatologic conditions Pregnant or breastfeeding women Patients who have previously undergone CO2 laser treatment within the past 3 months History of Keloid tendency Allergy to any treatment components (exosomes, PRP, etc.).

结局指标

主要结局

Goodman and Baron qualitative and quantitative scores will be used to assess the improvement in Acne scar during and post treatment.

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

Skin Texture Improvement will be assessed using Dermatologist Visual Scoring,

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

Evaluating the improvement in skin texture, including smoothness, clarity, and overall appearance.

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

Reduction in pigmentation is measured by pigmentation index score.

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

Over all skin improvement is assessed based on patient experience of improvement

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

Adverse events will be documented with its downtime with each procedure and side

时间窗: During Treatment: | Monthly sessions of exosome/PRP with CO2 laser for 3 months | Post-Treatment: | 1-month post-treatment: Follow-up visit and evaluation | 3 months post-treatment: Final assessment | Final picture comparisons with pre-treatment documentation both sides separately

次要结局

  • Patient satisfaction is assessed using a patient satisfaction scale.

研究者

发起方
MADADI PRGNYA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

MADADI PRAGNYA

KANACHUR INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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