PRP Plus Fractional CO₂ Laser for Acne Scars

Официальное название

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

Обзор

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.

Подробное описание

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.

Data will be analyzed using appropriate statistical methods. Continuous variables will be assessed for normality and compared using t-tests or nonparametric equivalents. Categorical and ordinal data will be analyzed using Chi-square or related tests. A significance level of p \< 0.05 will be applied. Data will be coded, and the statistician will remain blinded to group allocation.

The purpose of this trial is to determine whether PRP enhances the efficacy, safety profile, and patient satisfaction of fractional CO₂ laser treatments. If successful, this combination approach may offer a more effective therapeutic option for managing moderate-to-severe acne scarring.

Вмешательства

• Процедура Fractional CO₂ Laser + Platelet-Rich Plasma (PRP)
  Fractional CO₂ Laser + Platelet-Rich Plasma (PRP) Participants receive fractional CO₂ laser treatment followed by topical application of autologous platelet-rich plasma. Three treatment sessions are performed at four-week intervals. PRP is prepared using a standardized double-spin centrifugation method from 10 mL of the participant's blood. After laser resurfacing, the PRP is applied immediately to the treated area to enhance healing and collagen remodeling.
• Процедура Fractional CO₂ Laser Only
  Fractional CO₂ Laser Only Participants receive fractional CO₂ laser treatment alone, with the same laser settings and treatment schedule as the intervention group. Three sessions are performed at four-week intervals. To maintain participant blinding, a placebo-filled syringe covered with opaque tape is applied to the skin without delivering PRP.

Первичные конечные точки

• Change in Acne Scar Severity (Goodman and Baron Quantitative Acne Scar Scale) [Срок оценки: 12weeks]

Вторичные конечные точки (4)

• Redness (Erythema) Score [Срок оценки: 12weeks]
• Edema (Swelling) Score [Срок оценки: 12 weeks]
• Pain Score (11-Point Numeric Rating Scale) [Срок оценки: 12 weeks]
• Patient Satisfaction Rating [Срок оценки: 12 weeks]

Критерии участия

Inclusion Criteria: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 -

Exclusion Criteria: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)

Melasma

Active infections (e.g., Herpes simplex)

Recent laser resurfacing or similar procedures

Outdoor workers with high sun exposure

Vitiligo

Pregnancy or breastfeeding

Bleeding disorders or anticoagulant therapy

Unrealistic expectations or inability to comply with follow-up

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Destrict Head Quarter Hospital, Gujranwala — Gujranwala

Публикации

• Rullan PP, Olson R, Lee KC. A Combination Approach to Treating Acne Scars in All Skin Types: Carbolic Chemical Reconstruction of Skin Scars, Blunt Bi-level Cannula Subcision, and Microneedling-A Case Series. J Clin Aesthet Dermatol. 2020 May;13(5):19-23. Epub 2020 May 1. PMID 32802250
• Connolly D, Vu HL, Mariwalla K, Saedi N. Acne Scarring-Pathogenesis, Evaluation, and Treatment Options. J Clin Aesthet Dermatol. 2017 Sep;10(9):12-23. Epub 2017 Sep 1. PMID 29344322

Идентификаторы

NCT: NCT07352215 · No. IRB.22/ GMC · CPSP/REU/DER-2023-093-19340

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗