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.

November 1, 2026 updated by: 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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Riham M Mohamed, MD, MSc., PhD
Phone Number: +201066239360
Email: riham.mohye@cu.edu.eg

Study Locations

Egypt
- - Cairo, Egypt
    - Faculty of Medicine, Cairo University
    - Contact:
      
      Riham M Mohamed, MD, MSc., PhD
      
      Phone Number: +201066239360
      
      Email: riham.mohye@cu.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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. Other Names: FCO2 10,600 nm; DEKA SmartXide DOT, Italy
Experimental: 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.	Device: 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. Other Names: FCO2 10,600 nm; DEKA SmartXide DOT, Italy Drug: 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. Other Names: Botox

Participant Group / Arm

Intervention / Treatment

Active Comparator: 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.

Device: 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.

Other Names:

FCO2
10,600 nm; DEKA SmartXide DOT, Italy

Experimental: 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.

Device: Fractional co2 laser

Other Names:

FCO2
10,600 nm; DEKA SmartXide DOT, Italy

Drug: 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.

Other Names:

Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in lesion count Time Frame: 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) Time Frame: 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The investigator Global Assessment Scale (IGA) Time Frame: 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) Time Frame: 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 Time Frame: 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) Time Frame: 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 Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 6, 2026

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

May 27, 2027

Study Registration Dates

First Submitted

November 1, 2026

First Submitted That Met QC Criteria

November 1, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 1, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

MS-379-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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.