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Comparison of Efficacy of Carbon Dioxide Laser With Subcision Versus Platelet-Rich Plasma Bio-Fillers With Subcision for the Treatment of Atrophic Acne

2026年8月3日 更新者：Muhammad Irfan Jamil、Lahore General Hospital

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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • パキスタン
    • Punjab Province
      • Lahore、Punjab Province、パキスタン、54000
        • Lahore General Hospital, Lahore

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人

健康ボランティアの受け入れ

いいえ

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：Platelet-Rich Plasma Bio-Filler With Subcision
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.
アクティブコンパレータ：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.
デバイス：Fractional Carbon Dioxide Laser With Subcision
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Patient and Observer Scar Assessment Scale Score
時間枠：Baseline and 4, 8, and 12 weeks after initiation of treatment.
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.
Baseline and 4, 8, and 12 weeks after initiation of treatment.
Proportion of Participants Achieving Treatment Efficacy
時間枠：12 weeks after initiation of treatment.
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.
12 weeks after initiation of treatment.

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Treatment-Related Pain
時間枠：At 4, 8, and 12 weeks after initiation of treatment.
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
At 4, 8, and 12 weeks after initiation of treatment.
Incidence of Treatment-Related Pigmentary Changes
時間枠：At 4, 8, and 12 weeks after initiation of treatment.
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.
At 4, 8, and 12 weeks after initiation of treatment.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Lahore General Hospital

捜査官

  • 主任研究者：Kainat Haq、Lahore General Hospital, Lahore

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年8月10日

一次修了 (実際)

2026年2月10日

研究の完了 (実際)

2026年2月10日

試験登録日

最初に提出

2026年8月3日

QC基準を満たした最初の提出物

2026年8月3日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月3日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • LahoreGeneralH17

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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