AcnePhase 3NCT07919886
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 Phase 3 study testing Fractional co2 laser and Botulinium Toxin-A in people with Acne and Acne Papulopustulosa, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne, Acne Papulopustulosa
- What is being tested?
- Fractional co2 laser and Botulinium Toxin-A
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Nov 2026to 27 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine, Cairo University
Cairo
Riham M Mohamed, MD, MSc., PhD, +201066239360, riham.mohye@cu.edu.eg
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- Acne, Acne Papulopustulosa
- Being tested
- Fractional co2 laser, Botulinium Toxin-A
- Keywords
- acne, inflammatory acne, fractional CO2 Laser, Botulinum toxin A, microbotox
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional co2 laserDevice
Also called FCO2, 10,600 nm; DEKA SmartXide DOT, Italy
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.
Botulinium Toxin-ADrug
Also called Botox
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.
| Study group | Role | What they receive |
|---|---|---|
| Fractional CO₂ Laser | Active comparator | * 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. Receives: Device: Fractional co2 laser |
| Fractional CO₂ laser combined with intradermal microbotox injection. | Experimental | * 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. Receives: Device: Fractional co2 laser; Drug: Botulinium Toxin-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in lesion count
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).
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Global Acne Grading System (GAGS)
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).
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Secondary outcomes (5)
The investigator Global Assessment Scale (IGA)
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)
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Cardiff Acne Disability Index (CADI)
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)
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Patient satisfaction score
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.
Measured: At 24 weeks
The Post-Acne Hyperpigmentation Index (PAHPI)
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).
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Post-inflammatory erythema grading system
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).
Measured: Upon enrollment, at 12 weeks and at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start6 Nov 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective split-face assessor-blinded randomized comparative study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riham Mohyeeldeen Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919886
- Sponsor's protocol ID
- MS-379-2025
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kakpovbia EE, Young T, Milam EC, Qian Y, Yassin S, Nicholson J, Hu J, Troxel AB, Nagler AR. Efficacy of topical treatments for mild-to-moderate acne: A systematic review and meta-analysis of randomized control trials. J Eur Acad Dermatol Venereol. 2025 Apr;39(4):775-784. doi: 10.1111/jdv.20154. Epub 2024 Jun 29.
PubMed 38943431Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.
PubMed 38300170Ibrahim SM, Farag A, Hegazy R, Mongy M, Shalaby S, Kamel MM. Combined Low-Dose Isotretinoin and Pulsed Dye Laser Versus standard-Dose Isotretinoin in the Treatment of Inflammatory Acne. Lasers Surg Med. 2021 Jul;53(5):603-609. doi: 10.1002/lsm.23356. Epub 2020 Nov 13.
PubMed 33185932Hammoda TM, Ahmed NA, Hamdino M. Fractional CO2 laser versus 1064-nm long-pulsed Nd:YAG laser for inflammatory acne vulgaris treatment: a randomized clinical trial. Lasers Med Sci. 2023 Aug 18;38(1):187. doi: 10.1007/s10103-023-03855-6.
PubMed 37592125Gad El-Karim MA, Hegazy MS, Maged A, Fawzy SK, Abdelghani R. Efficacy and safety of combined fractional carbon dioxide laser and topical timolol maleate 0.5% solution versus topical timolol maleate 0.5% solution alone in inflammatory facial acne; a randomized split face controlled study. Lasers Med Sci. 2025 Feb 1;40(1):58. doi: 10.1007/s10103-025-04308-y.
PubMed 39891790Calvisi L, Diaspro A, Sito G. Microbotox: A prospective evaluation of dermatological improvement in patients with mild-to-moderate acne and erythematotelangiectatic rosacea. J Cosmet Dermatol. 2022 Sep;21(9):3747-3753. doi: 10.1111/jocd.14692. Epub 2022 Mar 21.
PubMed 35312149
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07919886
- Acronym / sponsor ID
- MS-379-2025
- Conditions
- Acne, Acne Papulopustulosa
- Keywords
- acne, inflammatory acne, fractional CO2 Laser, Botulinum toxin A, microbotox
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Nov 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective split-face assessor-blinded randomized comparative study
| Arm | Type | Receives |
|---|---|---|
| Fractional CO₂ Laser | Active comparator | Device: 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. |
| Fractional CO₂ laser combined with intradermal microbotox injection. | Experimental | Device: Fractional co2 laser, Drug: Botulinium Toxin-A* 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional co2 laserAlso: FCO2, 10,600 nm; DEKA SmartXide DOT, ItalyThe 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. | Device | Fractional CO₂ Laser, Fractional CO₂ laser combined with intradermal microbotox injection. |
| Botulinium Toxin-AAlso: BotoxIntradermal 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. | Drug | Fractional CO₂ laser combined with intradermal microbotox injection. |
Primary outcome
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).
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).
5 secondary outcomes
The investigator Global Assessment Scale (IGA)
Time frame: 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
Patient satisfaction score
Time frame: At 24 weeks
The Post-Acne Hyperpigmentation Index (PAHPI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 38943431Kakpovbia EE, Young T, Milam EC, Qian Y, Yassin S, Nicholson J, Hu J, Troxel AB, Nagler AR. Efficacy of topical treatments for mild-to-moderate acne: A systematic review and meta-analysis of randomized control trials. J Eur Acad Dermatol Venereol. 2025 Apr;39(4):775-784. doi: 10.1111/jdv.20154. Epub 2024 Jun 29.
- Background: PubMed 38300170Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.
- Background: PubMed 33185932Ibrahim SM, Farag A, Hegazy R, Mongy M, Shalaby S, Kamel MM. Combined Low-Dose Isotretinoin and Pulsed Dye Laser Versus standard-Dose Isotretinoin in the Treatment of Inflammatory Acne. Lasers Surg Med. 2021 Jul;53(5):603-609. doi: 10.1002/lsm.23356. Epub 2020 Nov 13.
- Background: PubMed 37592125Hammoda TM, Ahmed NA, Hamdino M. Fractional CO2 laser versus 1064-nm long-pulsed Nd:YAG laser for inflammatory acne vulgaris treatment: a randomized clinical trial. Lasers Med Sci. 2023 Aug 18;38(1):187. doi: 10.1007/s10103-023-03855-6.
- Background: PubMed 39891790Gad El-Karim MA, Hegazy MS, Maged A, Fawzy SK, Abdelghani R. Efficacy and safety of combined fractional carbon dioxide laser and topical timolol maleate 0.5% solution versus topical timolol maleate 0.5% solution alone in inflammatory facial acne; a randomized split face controlled study. Lasers Med Sci. 2025 Feb 1;40(1):58. doi: 10.1007/s10103-025-04308-y.
- Background: PubMed 35312149Calvisi L, Diaspro A, Sito G. Microbotox: A prospective evaluation of dermatological improvement in patients with mild-to-moderate acne and erythematotelangiectatic rosacea. J Cosmet Dermatol. 2022 Sep;21(9):3747-3753. doi: 10.1111/jocd.14692. Epub 2022 Mar 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fractional co2 laser and Botulinium Toxin-A in people with Acne and Acne Papulopustulosa, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riham M Mohamed, MD, MSc., PhD (+201066239360, riham.mohye@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in lesion count (time frame: Upon enrollment, at 12 weeks and at 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07919886, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.