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临床试验/CTRI/2025/07/091386
CTRI/2025/07/091386尚未招募不适用

Evaluating the effectiveness of Fractional CO2 laser versus Microneedling Radiofrequency and their combination with Epidermal growth factor in treating acne scars.

Dr Nirupama Bhagyalakshmi Tatavarthi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月4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
The primary outcomes were changes in Goodman and Baron

研究概览

简要总结

This research is a prospective, randomized, open-labeled interventional study designed to evaluate the effectiveness of various treatment modalities for acne scars. The treatments assessed include Fractional CO2 laser and Microneedling Radiofrequency, both as standalone therapies and in combination with topical Epidermal Growth Factor. A total of sixty patients aged between fifteen and forty years with post acne scarring of grades two to four were enrolled. Patients were selected from the outpatient dermatology department of ASRAM Hospital, Eluru.

The participants were randomly divided into four equal groups of fifteen patients each. Group A received treatment with Fractional CO2 laser. Group B received Fractional CO2 laser along with topical application of Epidermal Growth Factor. Group C was treated using Microneedling Radiofrequency alone, and Group D received Microneedling Radiofrequency combined with Epidermal Growth Factor. Each patient underwent a total of four treatment sessions spaced one month apart. A final follow-up was conducted two months after the last session to assess treatment outcomes.

Efficacy and safety outcomes were assessed using the Goodman and Baron quantitative and qualitative scoring system to measure acne scar severity before and after treatment. Patient satisfaction was evaluated using a visual analogue scale. Side effects were monitored immediately after each session, one week after each session, and two months after the final session. Clinical photographs were taken to document visual improvements in scar appearance.

Data were entered into Microsoft Excel and statistical analysis was conducted using IBM SPSS trial version twenty six. Continuous data were expressed as mean with standard deviation and categorical data were reported in percentages. One way analysis of variance was used to compare the mean outcomes among the four groups. A p value less than zero point zero five was considered statistically significant. Confidence intervals were calculated at ninety five percent.

The study aims to identify the most effective and safest treatment approach for acne scars, particularly in individuals with darker skin tones where the risk of post inflammatory hyperpigmentation is higher. The research also explores whether the addition of Epidermal Growth Factor to either laser or radiofrequency treatments improves scar healing and patient satisfaction while minimizing side effects and downtime. The findings are expected to support clinical decision making by highlighting the optimal combination of therapies for acne scar management.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Emotionally balanced patients with realistic expectations, Patients diagnosed of having post acne scarring grade 2 to 4, Patients who have not undergone any other procedures for scarring in last 6 weeks.

排除标准

  • Patients with active bacterial or viral infections, keloidal, bleeding tendency, with unrealistic expectations, unable for follow up, pregnant and lactating women.

结局指标

主要结局

The primary outcomes were changes in Goodman and Baron

时间窗: A total of four treatment sessions as per the group at an interval of one month | Last follow-up was carried out at the end of 2 months after the fourth session | At the end of 2 months after the last session – reduction of Goodman and Baron quantitative, qualitative scores, patient satisfaction score ( Visual analogue scale) & photographs were recorded. | Side effects recorded immediately, after 1 week of each session, 2 months after last session.

quantitative and qualitative scar grading scores

时间窗: A total of four treatment sessions as per the group at an interval of one month | Last follow-up was carried out at the end of 2 months after the fourth session | At the end of 2 months after the last session – reduction of Goodman and Baron quantitative, qualitative scores, patient satisfaction score ( Visual analogue scale) & photographs were recorded. | Side effects recorded immediately, after 1 week of each session, 2 months after last session.

次要结局

  • patient satisfaction (assessed by Visual Analog Scale), and(evaluation of treatment-related side effects.)

研究者

发起方
Dr Nirupama Bhagyalakshmi Tatavarthi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Nirupama Bhagyalakshmi Tatavarthi

Alluri Sitarama Raju Academy Of Medical Sciences

研究点 (1)

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