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临床试验/NCT07352215
NCT07352215招募中不适用

Evaluating the Effectiveness of Platelet-Rich Plasma as an Adjunct to Fractional Carbon Dioxide Laser Therapy in Improving Facial Acne Scar Appearance: A Randomized Controlled Trial

Gujranwala medical college District Headquarters Hospital, Gujranwala0 个研究点目标入组 70 人开始时间: 2025年10月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70

研究概览

简要总结

This randomized controlled trial aims to evaluate whether adding platelet-rich plasma (PRP) to fractional CO₂ laser resurfacing improves the treatment of moderate-to-severe acne scars compared with laser alone. Seventy adults aged 18-40 years will be recruited from the Dermatology Department of Gujranwala Medical College Teaching Hospital. Participants will be randomly assigned to receive either fractional CO₂ laser combined with topical PRP or fractional CO₂ laser alone, with three treatment sessions delivered four weeks apart.

The primary outcome is the change in acne scar severity measured using the Goodman and Baron Quantitative Acne Scar Scale. Secondary outcomes include redness, edema, pain scores, and patient satisfaction assessed using Likert and numeric rating scales. The study is single-blinded, with patients unaware of treatment allocation. PRP will be prepared using a standardized double-spin centrifugation process. Data will be analyzed using appropriate statistical tests with a significance level of p < 0.05. The study aims to determine whether PRP enhances laser efficacy, reduces side effects, and improves patient-reported outcomes.

详细描述

Acne scarring is a frequent and distressing outcome of acne vulgaris. Fractional carbon dioxide (CO₂) laser therapy is widely used for acne scar management because it creates controlled microthermal zones that stimulate collagen remodeling and improve skin texture. However, laser treatment alone may lead to side effects such as erythema, edema, discomfort, and variable degrees of clinical improvement.

Platelet-rich plasma (PRP) is an autologous biological product containing high concentrations of platelets, growth factors, and cytokines known to promote wound healing, enhance collagen production, and modulate inflammation. The combination of PRP with fractional CO₂ laser treatment is believed to enhance clinical results, improve healing time, and reduce post-procedural complications. This study is designed to evaluate whether adding PRP to fractional CO₂ laser improves outcomes for patients with moderate-to-severe acne scars.

This randomized controlled trial will recruit 70 patients aged 18-40 years with moderate-to-severe facial acne scars. Participants will be randomly allocated into two groups. Group A will receive fractional CO₂ laser therapy combined with PRP, and Group B will receive fractional CO₂ laser therapy alone. Both groups will undergo three treatment sessions spaced four weeks apart. The study uses single blinding, where patients are unaware of their treatment assignment. To maintain blinding, a placebo-filled syringe will be used in the control group and gently applied without injecting any substance.

PRP will be prepared using a standardized double-spin method. Ten milliliters of venous blood will be collected in anticoagulant tubes, centrifuged at low speed to separate plasma and buffy coat, followed by a second high-speed centrifugation to isolate platelet-rich plasma. Topical anesthesia with lignocaine-prilocaine cream will be applied before each laser session. Treatment areas will be prepared using antiseptic measures, and eye protection will be provided.

Outcome assessment will be performed at baseline and at each visit. The primary outcome is the change in acne scar severity measured using the Goodman and Baron Quantitative Acne Scar Scale. Secondary outcomes include assessments of erythema and edema by the evaluator, as well as patient-reported pain scores and satisfaction ratings. Standardized clinical photographs will support patient self-assessment under consistent lighting and camera settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

This study uses single masking. Participants are blinded to their group assignment by placebo-filled syringes covered with opaque tape applied to the skin without injection to mimic the appearance and procedure of PRP application in control group.

The treating physician and study staff are aware of the allocation, while the patients and the outcome statistician remain blinded to group identity.

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 40 years
  • Male and female participants
  • Fitzpatrick skin types I to V
  • Presence of moderate-to-severe acne scars
  • Willing to undergo 3 treatment sessions and follow-up visits
  • Able to provide informed consent -

排除标准

  • Use of topical anti-acne medications in the past 1 month
  • History of keloid formation or hypertrophic scarring
  • Active acne or active skin inflammation at treatment area
  • Diabetes mellitus
  • Photosensitive disorders (e.g., lupus, dermatomyositis)
  • Active infections (e.g., Herpes simplex)
  • Recent laser resurfacing or similar procedures
  • Outdoor workers with high sun exposure
  • Pregnancy or breastfeeding
  • Bleeding disorders or anticoagulant therapy
  • Unrealistic expectations or inability to comply with follow-up

研究者

发起方
Gujranwala medical college District Headquarters Hospital, Gujranwala
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasaan Saaqib

Principal investigator

Gujranwala medical college District Headquarters Hospital, Gujranwala

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