Comparison of Efficacy of Carbon Dioxide Laser With Subcision Versus Platelet-Rich Plasma Bio-Fillers With Subcision for the Treatment of Atrophic Acne
This randomized controlled trial compared two combined treatment approaches for atrophic acne scars. A total of 100 patients aged 15-45 years were enrolled from the Department of Dermatology, Lahore General Hospital, Lahore, and were randomly assigned to one of two treatment groups. All participants underwent subcision, a minor procedure in which fibrous bands beneath depressed acne scars were released to elevate the scarred skin.
Participants in one group received platelet-rich plasma bio-filler injections after subcision. The bio-filler was prepared from each participant's own blood and was injected beneath the acne scars to provide volume and promote collagen formation. Participants in the other group received fractional carbon dioxide laser treatment after subcision. The laser created controlled microscopic skin injuries intended to stimulate collagen production and improve skin texture. Three treatment sessions were administered at 4-week intervals.
Treatment outcomes were assessed using the Patient and Observer Scar Assessment Scale at baseline and during follow-up. Treatment-related adverse effects, including pain, erythema, bruising, and changes in skin pigmentation, were also recorded. Treatment efficacy was defined as a reduction of more than 50% in acne scar severity.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54000
- Lahore General Hospital, Lahore
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Patients of age 15-45 years,
- both genders,
- presenting with atrophic acne scars
Exclusion Criteria:
- Patients with photosensitive dermatosis, keloids, active acne, already taking steroidal, laser or trial treatment in last 6 months, hepatitis B or hepatitis C, hypothyroidism (TSH>5IU), pregnant or breast feeding, skin infection or inflammatory skin disorders requiring systemic antimicrobials (on medical record).
- Patients with connective tissue disorders or hypersensitivity to lidocaine, taking antiplatelet therapy, bleeding tendencies (on clinical examination)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Platelet-Rich Plasma Bio-Filler With Subcision
Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements.
After subcision, 0.1 mL of autologous plasma bio-filler was injected intradermally beneath each marked atrophic acne scar.
Three treatment sessions were administered at 4-week intervals.
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Autologous plasma bio-filler was prepared from 20 mL of venous blood.
The blood was centrifuged at 1,500 revolutions per minute for 10 minutes, followed by a second centrifugation at 3,000 revolutions per minute for 10 minutes.
Approximately 4-5 mL of the upper plasma layer was collected, heated at 80-100°C for 5 minutes, and subsequently cooled at 0-6°C for 5 minutes to produce a viscous bio-filler.
Following subcision, 0.1 mL of the bio-filler was injected beneath each marked scar.
Three treatment sessions were provided at 4-week intervals.
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有源比较器：Fractional Carbon Dioxide Laser With Subcision
Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements.
Subcision was followed by a single pass of fractional carbon dioxide laser treatment.
Three treatment sessions were administered at 4-week intervals.
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After subcision, the treatment area received a single pass of fractional carbon dioxide laser using a pulse energy of 25 mJ, spot density of 144 spots/cm², pulse interval of 0.5 mm, and pulse duration of 0.1 milliseconds.
Three treatment sessions were provided at 4-week intervals.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Patient and Observer Scar Assessment Scale Score
大体时间：Baseline and 4, 8, and 12 weeks after initiation of treatment.
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Atrophic acne scar severity was assessed using the Patient and Observer Scar Assessment Scale.
The scale was completed at baseline and at each follow-up assessment.
The change in score from baseline was calculated for each participant and compared between the two treatment groups.
A greater reduction from the baseline score represented greater improvement in acne scar severity.
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Baseline and 4, 8, and 12 weeks after initiation of treatment.
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Proportion of Participants Achieving Treatment Efficacy
大体时间：12 weeks after initiation of treatment.
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Treatment efficacy was defined as a reduction of more than 50% in atrophic acne scar severity compared with baseline.
The reduction was determined using the Patient and Observer Scar Assessment Scale.
The number and percentage of participants achieving treatment efficacy were calculated for each treatment group.
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12 weeks after initiation of treatment.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Treatment-Related Pain
大体时间：At 4, 8, and 12 weeks after initiation of treatment.
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Treatment-related pain was assessed at each follow-up visit and recorded as present or absent.
The number and percentage of participants experiencing pain were compared between the two treatment groups
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At 4, 8, and 12 weeks after initiation of treatment.
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Incidence of Treatment-Related Pigmentary Changes
大体时间：At 4, 8, and 12 weeks after initiation of treatment.
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Hypopigmentation or hyperpigmentation occurring in the treated area was assessed by clinical examination and recorded as present or absent.
The number and percentage of participants developing pigmentary changes were calculated for each treatment group.
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At 4, 8, and 12 weeks after initiation of treatment.
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合作者和调查者
调查人员
- 首席研究员：Kainat Haq、Lahore General Hospital, Lahore
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- LahoreGeneralH17
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