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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 listopada 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

24

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Egipt
      • Cairo, Egipt
        • Faculty of Medicine, Cairo University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 45 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Urządzenie: 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.

Inne nazwy:
  • FCO2
  • 10,600 nm; DEKA SmartXide DOT, Italy
Eksperymentalny: 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.
Urządzenie: 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.

Inne nazwy:
  • FCO2
  • 10,600 nm; DEKA SmartXide DOT, Italy
Lek: 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.
Inne nazwy:
  • Botoks

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage change in lesion count
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
The investigator Global Assessment Scale (IGA)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Cairo University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

6 listopada 2026

Zakończenie podstawowe (Szacowany)

20 maja 2027

Ukończenie studiów (Szacowany)

27 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

1 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 listopada 2026

Pierwszy wysłany (Rzeczywisty)

5 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • MS-379-2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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