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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.

1 novembre 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

24

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Riham M Mohamed, MD, MSc., PhD
  • Numéro de téléphone: +201066239360
  • E-mail: riham.mohye@cu.edu.eg

Lieux d'étude

  • Egypte
      • Cairo, Egypte
        • Faculty of Medicine, Cairo University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 45 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Dispositif: 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.

Autres noms:
  • FCO2
  • 10,600 nm; DEKA SmartXide DOT, Italy
Expérimental: 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.
Dispositif: 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.

Autres noms:
  • FCO2
  • 10,600 nm; DEKA SmartXide DOT, Italy
Médicament: 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.
Autres noms:
  • Botox

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage change in lesion count
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The investigator Global Assessment Scale (IGA)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Cairo University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

6 novembre 2026

Achèvement primaire (Estimé)

20 mai 2027

Achèvement de l'étude (Estimé)

27 mai 2027

Dates d'inscription aux études

Première soumission

1 novembre 2026

Première soumission répondant aux critères de contrôle qualité

1 novembre 2026

Première publication (Réel)

5 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • MS-379-2025

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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