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Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.

2026年11月1日更新者：Riham Mohyeeldeen Mohamed、Cairo University

Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris: A Split-face Randomized Controlled Trial.

The goal of this clinical trial is to learn if fractional CO₂ laser (FCO₂) with and without intradermal Botulinum Toxin A can treat inflammatory facial acne vulgaris in adult patients of both genders. It will also learn about the safety and tolerability of fractional CO₂ laser (FCO₂) with and without intradermal Botulinum Toxin A in patients with inflammatory facial acne vulgaris.

The main questions it aims to answer is:

Does fractional CO₂ laser (FCO₂) work effectively in inflammatory facial acne vulgaris?
is fractional CO₂ laser (FCO₂) well tolerated in inflammatory facial acne vulgaris?
Is fractional CO₂ laser (FCO₂) monotherapy comparable to fractional CO₂ laser (FCO₂) combined with intradermal Botulinum Toxin A in terms of efficacy and safety in inflammatory facial acne vulgaris?

Researchers will compare fractional CO₂ laser (FCO₂) monotherapy to fractional CO₂ laser (FCO₂) combined with intradermal Botulinum Toxin A to see if crisaborole works as effective and is as well-tolerated in inflammatory facial acne vulgaris.

Participants will:

Visit the Dermatology clinic to undergo a single session of intradermal Botulinum Toxin A injection to one randomized hemi-face.
- Then 2 weeks later, they will visit the Dermatology LASER clinic to start fractional CO₂ laser (FCO₂) sessions every 4 weeks, also for checkups and photography.
- They will receive a total of 3 FCO₂ LASER sessions (4 weeks apart).
- Then 12 weeks after the last session, they will visit the clinic for follow up, photography and documentation.
Keep a diary of their symptoms

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

The proposed study is a single-center prospective split-face open-label, assessor-blinded randomized controlled clinical trial that will enroll adult patients with inflammatory facial acne vulgaris who will be recruited at the Dermatology outpatient clinic at Kasr Alainy University Hospitals.

The study aims to evaluate the efficacy, safety, and tolerability of fractional CO₂ laser (FCO₂) with and without intradermal Botulinum Toxin A in the treatment of inflammatory facial acne. The study will involve 24 patients with inflammatory facial acne. The purpose and nature of the study will be explained to all patients. Written informed consent for participation, treatment, and photography will be obtained from each patient prior to enrollment in the study.

研究の種類

介入

入学 (推定)

段階

フェーズ 3

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。

研究連絡先

名前：Riham M Mohamed, MD, MSc., PhD
電話番号：+201066239360
メール：riham.mohye@cu.edu.eg

研究場所

エジプト
- - Cairo、エジプト
    - Faculty of Medicine, Cairo University
    - コンタクト：
      
      Riham M Mohamed, MD, MSc., PhD
      
      電話番号：+201066239360
      
      メール：riham.mohye@cu.edu.eg

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

18年～45年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

Patients with inflammatory facial acne with Global Evaluation Acne (GEA) scale (2-4).
Both genders.
Aged 18 - 45 years.
Willingness and ability to comply with the requirements of the protocol.

Exclusion Criteria:

Patients with exclusively non-inflammatory acne, very severe nodulocystic acne (GEA > 4), or non-facial acne.
Patients who were using or have discontinued systemic treatment for acne within 12 weeks prior to enrollment in the study. For oral isotretinoin, a washout period of 24 weeks was strictly applied.
Patients who were using or had discontinued topical acne treatments within 4 weeks prior to baseline of the study.
Patients who underwent, planned, or had discontinued facial procedures (e.g., chemical peels, laser, depilation) within 4 weeks prior to baseline in the treatment area.
Patients with active skin infections, such as herpes simplex virus (HSV), impetigo, or other bacterial, viral, or fungal skin infections.
Patients with neuromuscular disorders, e.g., myasthenia gravis.
Patients with known hypersensitivity or contraindications to botulinum toxin or FCO₂ laser therapy.
Patients with other facial rashes that might have interfered with accurate assessment.
Pregnancy or lactation.

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

アーム数

武器と介入

参加者グループ / アーム	介入・治療
アクティブコンパレータ：Fractional CO₂ Laser Each participant will undergo a total of 3 FCO₂ laser sessions, scheduled at four-week intervals. Laser sessions will be initiated 2 weeks after intradermal microbotox injections on the designated side. Laser safety goggles will be used for all patients throughout the procedure. A fractional CO₂ laser system (10,600 nm; DEKA SmartXide DOT, Italy) will be used in all sessions. The treatment protocol comprises 2 overlapping passes over acne lesions, while perilesional and uninvolved skin will receive a single pass. Laser settings will be standardized at 15 W power, 550 μm dot spacing, 400 μs dwell time, using SmartTrack scanning mode with single stack emission. A square pattern with a 10/10 ratio and 100% spot size will be applied. The same laser settings will be used on both sides in each patient. If adjustment for phototype is required, it will be applied symmetrically to both sides and documented.	デバイス：Fractional co2 laser The treatment protocol comprises two overlapping passes over acne lesions, while perilesional and uninvolved skin receives a single pass. Laser settings were standardized at 15 W power, 550 μm dot spacing, 400 μs dwell time, using SmartTrack scanning mode with single stack emission. A square pattern with a 10/10 ratio and 100% spot size will be applied. 他の名前： FCO2 10,600 nm; DEKA SmartXide DOT, Italy
実験的：Fractional CO₂ laser combined with intradermal microbotox injection. A single session of intradermal microbotox injections will be performed 2 weeks prior to FCO₂ laser sessions on the allocated side. Topical anesthetic cream (lidocaine 2.5%/prilocaine 2.5%) will be applied to the treatment area for approximately 30 minutes prior to injection to minimize patient discomfort. Following adequate anesthesia, the anesthetic cream will be completely removed, and the skin will be disinfected with 70% isopropyl alcohol before injection. Botox® (onabotulinumtoxinA) will be used. Each vial containing 100 units will be reconstituted with 5 mL of sterile normal saline (0.9% NaCl), yielding a concentration of 20 units/mL. The diluted toxin will be administered intradermally using an insulin syringe fitted with a 30-gauge needle. Injections will be delivered at an angle of approximately 5-15° relative to the skin surface to ensure proper intradermal placement. • The total injected dose will be standardized at 20 units per hemi-face.	デバイス：Fractional co2 laser The treatment protocol comprises two overlapping passes over acne lesions, while perilesional and uninvolved skin receives a single pass. Laser settings were standardized at 15 W power, 550 μm dot spacing, 400 μs dwell time, using SmartTrack scanning mode with single stack emission. A square pattern with a 10/10 ratio and 100% spot size will be applied. 他の名前： FCO2 10,600 nm; DEKA SmartXide DOT, Italy 薬：Botulinium Toxin-A Intradermal botulinum toxin injection will be performed to one randomized hemi-face in each patient 2 weeks prior to starting FCO2 LASER sessions. Botox® (onabotulinumtoxinA), manufactured by Allergan (Irvine, California, USA), will be used. Each vial containing 100 units will be reconstituted with 5 mL of sterile normal saline (0.9% NaCl), yielding a concentration of 20 units/mL. The diluted toxin will be administered intradermally using an insulin syringe fitted with a 30-gauge needle. Injections will be delivered at an angle of approximately 5-15° relative to the skin surface to ensure proper intradermal placement, evidenced by the formation of small visible wheals at the injection sites. Microinjections will be spaced approximately 1 cm apart over the designated side of the face. The total injected dose will be standardized at 20 units per hemi-face. Care will be taken to avoid deep intramuscular injection to minimize the risk of unintended muscle weakness. 他の名前：ボトックス

参加者グループ / アーム

介入・治療

アクティブコンパレータ：Fractional CO₂ Laser

Each participant will undergo a total of 3 FCO₂ laser sessions, scheduled at four-week intervals. Laser sessions will be initiated 2 weeks after intradermal microbotox injections on the designated side.
Laser safety goggles will be used for all patients throughout the procedure.
A fractional CO₂ laser system (10,600 nm; DEKA SmartXide DOT, Italy) will be used in all sessions. The treatment protocol comprises 2 overlapping passes over acne lesions, while perilesional and uninvolved skin will receive a single pass. Laser settings will be standardized at 15 W power, 550 μm dot spacing, 400 μs dwell time, using SmartTrack scanning mode with single stack emission. A square pattern with a 10/10 ratio and 100% spot size will be applied.
The same laser settings will be used on both sides in each patient. If adjustment for phototype is required, it will be applied symmetrically to both sides and documented.

デバイス：Fractional co2 laser

The treatment protocol comprises two overlapping passes over acne lesions, while perilesional and uninvolved skin receives a single pass. Laser settings were standardized at 15 W power, 550 μm dot spacing, 400 μs dwell time, using SmartTrack scanning mode with single stack emission. A square pattern with a 10/10 ratio and 100% spot size will be applied.

他の名前：

FCO2
10,600 nm; DEKA SmartXide DOT, Italy

実験的：Fractional CO₂ laser combined with intradermal microbotox injection.

A single session of intradermal microbotox injections will be performed 2 weeks prior to FCO₂ laser sessions on the allocated side.
Topical anesthetic cream (lidocaine 2.5%/prilocaine 2.5%) will be applied to the treatment area for approximately 30 minutes prior to injection to minimize patient discomfort. Following adequate anesthesia, the anesthetic cream will be completely removed, and the skin will be disinfected with 70% isopropyl alcohol before injection.
Botox® (onabotulinumtoxinA) will be used. Each vial containing 100 units will be reconstituted with 5 mL of sterile normal saline (0.9% NaCl), yielding a concentration of 20 units/mL.
The diluted toxin will be administered intradermally using an insulin syringe fitted with a 30-gauge needle. Injections will be delivered at an angle of approximately 5-15° relative to the skin surface to ensure proper intradermal placement. • The total injected dose will be standardized at 20 units per hemi-face.

デバイス：Fractional co2 laser

他の名前：

FCO2
10,600 nm; DEKA SmartXide DOT, Italy

薬：Botulinium Toxin-A

Intradermal botulinum toxin injection will be performed to one randomized hemi-face in each patient 2 weeks prior to starting FCO2 LASER sessions.

Botox® (onabotulinumtoxinA), manufactured by Allergan (Irvine, California, USA), will be used. Each vial containing 100 units will be reconstituted with 5 mL of sterile normal saline (0.9% NaCl), yielding a concentration of 20 units/mL.
The diluted toxin will be administered intradermally using an insulin syringe fitted with a 30-gauge needle. Injections will be delivered at an angle of approximately 5-15° relative to the skin surface to ensure proper intradermal placement, evidenced by the formation of small visible wheals at the injection sites. Microinjections will be spaced approximately 1 cm apart over the designated side of the face.
The total injected dose will be standardized at 20 units per hemi-face.
Care will be taken to avoid deep intramuscular injection to minimize the risk of unintended muscle weakness.

他の名前：

ボトックス

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
Percentage change in lesion count 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	lesion count will be performed to each hemi-face respectively upon enrollment and at the end of treatment period and at the follow up visit (3 months past cessation of treatment).	Upon enrollment, at 12 weeks and at 24 weeks
Global Acne Grading System (GAGS) 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	With separate right and left cheek scoring in concordance with the split-face design. In 1997, Doshi et al. introduced the Global Acne Grading System (GAGS), which divides the face, chest, and back into six areas. Each area is graded from 0 to 4 based on the severity of the worst lesion. These individual scores are summed to produce a total score. Patients are classified as follows: 1-18 indicates mild acne, 19-30 indicates moderate acne, 31-38 indicates severe acne, and over 39 indicates very severe acne (Doshi, Zaheer and Stiller, 1997).	Upon enrollment, at 12 weeks and at 24 weeks

二次結果の測定

結果測定	メジャーの説明	時間枠
The investigator Global Assessment Scale (IGA) 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	is a clinician-rated scale used to evaluate overall acne severity and treatment response based on a global assessment of lesion appearance. It grades acne from clear (0) to severe (4)	Upon enrollment, at 12 weeks and at 24 weeks
Cardiff Acne Disability Index (CADI) 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	Acne-related quality of life will be assessed using the CADI, a validated acne-specific quality of life questionnaire developed by Motley and Finlay in 1992 to assess the psychological and social impact of acne vulgaris. It consists of five items scored on a four-point scale, with higher scores indicating greater impairment. It remains widely used in clinical research due to its simplicity and reliability (Motley and Finlay, 1992)	Upon enrollment, at 12 weeks and at 24 weeks
Patient satisfaction score 時間枠：At 24 weeks	Patient satisfaction will be assessed using a 5-point Likert scale to evaluate patients' subjective perception of treatment outcomes. On the Likert scale, patients will rate their overall satisfaction as 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.	At 24 weeks
The Post-Acne Hyperpigmentation Index (PAHPI) 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	is a validated scoring system developed to assess the severity of PIH based on lesion number, size, intensity, and distribution, with weighted scores assigned to each domain. The total PAHPI score ranges from 6 to 22, with higher scores indicating greater severity of post-acne hyperpigmentation. The index has demonstrated good reliability and validity in evaluating post-inflammatory hyperpigmentation associated with acne vulgaris (Khee et al., 2021).	Upon enrollment, at 12 weeks and at 24 weeks
Post-inflammatory erythema grading system 時間枠：Upon enrollment, at 12 weeks and at 24 weeks	is a clinician-based assessment tool used to evaluate the severity and extent of post-acne erythema following inflammatory acne lesions. It provides a standardized clinical evaluation of erythematous post-acne changes (Shucheng et al., 2024).	Upon enrollment, at 12 weeks and at 24 weeks

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

Cairo University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

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 (推定)

2026年11月6日

一次修了 (推定)

2027年5月20日

研究の完了 (推定)

2027年5月27日

試験登録日

最初に提出

2026年11月1日

QC基準を満たした最初の提出物

2026年11月1日

最初の投稿 (実際)

2026年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月1日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

MS-379-2025

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.