AcneNCT06909344
577-nm Diode Laser in the Treatment of Non -Inflammatory Acne
A study testing 577 nm Diode laser in people with Acne, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the clinical efficacy and safety of the 577 nm diode laser in the treatment of non -inflammatory acne. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- 577 nm Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with acne comedones
- Patients' ages range from 18-40 years.
- Minimum 10 comedonal lesions on both half of the face
Who cannot join
- Patients with systemic disease interfere with healing.
- Patients with Photosensitivity.
- Pregnant or lactating females.
- Previous topical, systemic, laser, surgical treatment and comedogenic drugs in the last 3 months.
- Skin cancer or suspicious lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of 577-nm Diode Laser in the Treatment of Non -Inflammatory Acne
The aim of this study is to evaluate the clinical efficacy and safety of the 577 nm diode laser in the treatment of non -inflammatory acne.
Read the detailed description
Acne vulgaris is a prevalent skin condition categorized into two types: non-inflammatory (comedones) and inflammatory (papules, pustules, and nodules). It primarily affects adolescents and young adults, often leading to scarring and diminished self-esteem. Over 80% of teenagers experience acne, which can continue into adulthood. The psychological impacts are significant, as many individuals experience reduced self-esteem and heightened anxiety. Effective treatment and management are essential for enhancing the quality of life for those affected.
The pathogenesis of acne is influenced by multiple factors, including excess sebum production, follicular keratinization, Propionibacterium acnes colonization, and inflammation. Acne treatments typically include topical and oral medications. Topical options, such as retinoids and antibiotics, require frequent application, which can affect patient compliance. Topical antibiotics often show poor efficacy and can lead to recurrence. Additionally, topical retinoids may cause irritation, while oral medications can have more severe side effects. Systemic isotretinoin is effective but associated with high costs and significant side effects, including teratogenicity and dryness.
Laser treatment for acne, particularly the inflammatory type, has gained significant popularity in recent years. This therapy effectively reduces acne lesions by inhibiting overactive sebaceous glands and alleviating inflammation. The mechanism is believed to involve the activation of porphyrins produced by Propionibacterium acnes, leading to the destruction of their cell membranes. Lasers with a wavelength of 1064 nm have been specifically studied for acne treatment. Various laser systems, such as near-infrared lasers and radiofrequency devices, effectively destroy sebaceous glands. Additionally, light sources like blue lights and intense pulsed light (IPL) are being increasingly incorporated into standard medical treatments to improve therapeutic outcomes.
Several types of lasers have been used to treat acne vulgaris in recent years and have shown great results. IPL and the 1,064-nm Nd:YAG laser are effective in treating inflammatory facial acne vulgaris, with no significant difference in their effects on facial acne lesions. Nd:YAG laser treatment also leads to a reduction in the total number of comedones, similar to the improvement observed with inflammatory lesions.
Vascular lasers, particularly a 577-nm high-power optically pumped semiconductor laser, are effective and safe for treating inflammatory lesions, decreasing Propionibacterium acnes, and reducing the size and function of the pilosebaceous unit.
Effective management of acne comedones often requires consistent use of topical treatments for several weeks to see significant improvement. If over-the-counter options take a long time and require considerable effort, it may be beneficial to explore other therapeutic avenues.
- Conditions
- Acne
- Being tested
- 577 nm Diode laser
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
577 nm Diode laserDevice
All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control
| Study group | Role | What they receive |
|---|---|---|
| All patients will be treated with sessions of the 577 nm Diode laser on one side of the face | Active comparator | All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control Receives: Device: 577 nm Diode laser |
| other side of the face serve as a control arm without interventions | No intervention | All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control without any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of comedones, measured through clinical assessment before and after treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start29 Mar 2025
- Primary completion1 Nov 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Hassan Shehata Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909344
- Sponsor's protocol ID
- yellow laser in comedonal acne
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barbieri JS, Spaccarelli N, Margolis DJ, James WD. Approaches to limit systemic antibiotic use in acne: Systemic alternatives, emerging topical therapies, dietary modification, and laser and light-based treatments. J Am Acad Dermatol. 2019 Feb;80(2):538-549. doi: 10.1016/j.jaad.2018.09.055. Epub 2018 Oct 5.
PubMed 30296534Mavranezouli I, Daly CH, Welton NJ, Deshpande S, Berg L, Bromham N, Arnold S, Phillippo DM, Wilcock J, Xu J, Ravenscroft JC, Wood D, Rafiq M, Fou L, Dworzynski K, Healy E. A systematic review and network meta-analysis of topical pharmacological, oral pharmacological, physical and combined treatments for acne vulgaris. Br J Dermatol. 2022 Nov;187(5):639-649. doi: 10.1111/bjd.21739. Epub 2022 Aug 22.
PubMed 35789996Melnik BC. Acne Transcriptomics: Fundamentals of Acne Pathogenesis and Isotretinoin Treatment. Cells. 2023 Nov 10;12(22):2600. doi: 10.3390/cells12222600.
PubMed 37998335Alsohaimi AO, Alghamdi A, Alghamdi RS, Alghamdi AH, Alkhathami AM, Alghamdi MA, Alghamdi SA, Alzahrani NM, Alghamdi NS. Prevalence of Acne Vulgaris in Adolescents and Young Adults in Al-Baha Region, Saudi Arabia. Cureus. 2024 Oct 12;16(10):e71293. doi: 10.7759/cureus.71293. eCollection 2024 Oct.
PubMed 39529772
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of 577-nm Diode Laser in the Treatment of Non -Inflammatory Acne
- ClinicalTrials.gov ID
- NCT06909344
- Acronym / sponsor ID
- yellow laser in comedonal acne
- Conditions
- Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 3 Apr 2025 (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 aim of this study is to evaluate the clinical efficacy and safety of the 577 nm diode laser in the treatment of non -inflammatory acne.
Detailed description
Acne vulgaris is a prevalent skin condition categorized into two types: non-inflammatory (comedones) and inflammatory (papules, pustules, and nodules). It primarily affects adolescents and young adults, often leading to scarring and diminished self-esteem. Over 80% of teenagers experience acne, which can continue into adulthood. The psychological impacts are significant, as many individuals experience reduced self-esteem and heightened anxiety. Effective treatment and management are essential for enhancing the quality of life for those affected.
The pathogenesis of acne is influenced by multiple factors, including excess sebum production, follicular keratinization, Propionibacterium acnes colonization, and inflammation. Acne treatments typically include topical and oral medications. Topical options, such as retinoids and antibiotics, require frequent application, which can affect patient compliance. Topical antibiotics often show poor efficacy and can lead to recurrence. Additionally, topical retinoids may cause irritation, while oral medications can have more severe side effects. Systemic isotretinoin is effective but associated with high costs and significant side effects, including teratogenicity and dryness.
Laser treatment for acne, particularly the inflammatory type, has gained significant popularity in recent years. This therapy effectively reduces acne lesions by inhibiting overactive sebaceous glands and alleviating inflammation. The mechanism is believed to involve the activation of porphyrins produced by Propionibacterium acnes, leading to the destruction of their cell membranes. Lasers with a wavelength of 1064 nm have been specifically studied for acne treatment. Various laser systems, such as near-infrared lasers and radiofrequency devices, effectively destroy sebaceous glands. Additionally, light sources like blue lights and intense pulsed light (IPL) are being increasingly incorporated into standard medical treatments to improve therapeutic outcomes.
Several types of lasers have been used to treat acne vulgaris in recent years and have shown great results. IPL and the 1,064-nm Nd:YAG laser are effective in treating inflammatory facial acne vulgaris, with no significant difference in their effects on facial acne lesions. Nd:YAG laser treatment also leads to a reduction in the total number of comedones, similar to the improvement observed with inflammatory lesions.
Vascular lasers, particularly a 577-nm high-power optically pumped semiconductor laser, are effective and safe for treating inflammatory lesions, decreasing Propionibacterium acnes, and reducing the size and function of the pilosebaceous unit.
Effective management of acne comedones often requires consistent use of topical treatments for several weeks to see significant improvement. If over-the-counter options take a long time and require considerable effort, it may be beneficial to explore other therapeutic avenues.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All patients will be treated with sessions of the 577 nm Diode laser on one side of the face | Active comparator | Device: 577 nm Diode laserAll patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control |
| other side of the face serve as a control arm without interventions | No intervention | –All patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control without any interventions |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with acne comedones
- Patients' ages range from 18-40 years.
- Minimum 10 comedonal lesions on both half of the face
Key exclusion criteria (5 listed)
- Patients with systemic disease interfere with healing.
- Patients with Photosensitivity.
- Pregnant or lactating females.
- Previous topical, systemic, laser, surgical treatment and comedogenic drugs in the last 3 months.
- Skin cancer or suspicious lesions.
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 |
|---|---|---|
| 577 nm Diode laserAll patients will be treated with sessions of the 577 nm Diode laser on one side of the face and on the other side serve as a control | Device | All patients will be treated with sessions of the 577 nm Diode laser on one side of the face |
Primary outcome
Reduction in the number of comedones, measured through clinical assessment before and after treatment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 30296534Barbieri JS, Spaccarelli N, Margolis DJ, James WD. Approaches to limit systemic antibiotic use in acne: Systemic alternatives, emerging topical therapies, dietary modification, and laser and light-based treatments. J Am Acad Dermatol. 2019 Feb;80(2):538-549. doi: 10.1016/j.jaad.2018.09.055. Epub 2018 Oct 5.
- Results publication: PubMed 35789996Mavranezouli I, Daly CH, Welton NJ, Deshpande S, Berg L, Bromham N, Arnold S, Phillippo DM, Wilcock J, Xu J, Ravenscroft JC, Wood D, Rafiq M, Fou L, Dworzynski K, Healy E. A systematic review and network meta-analysis of topical pharmacological, oral pharmacological, physical and combined treatments for acne vulgaris. Br J Dermatol. 2022 Nov;187(5):639-649. doi: 10.1111/bjd.21739. Epub 2022 Aug 22.
- Results publication: PubMed 37998335Melnik BC. Acne Transcriptomics: Fundamentals of Acne Pathogenesis and Isotretinoin Treatment. Cells. 2023 Nov 10;12(22):2600. doi: 10.3390/cells12222600.
- Results publication: PubMed 39529772Alsohaimi AO, Alghamdi A, Alghamdi RS, Alghamdi AH, Alkhathami AM, Alghamdi MA, Alghamdi SA, Alzahrani NM, Alghamdi NS. Prevalence of Acne Vulgaris in Adolescents and Young Adults in Al-Baha Region, Saudi Arabia. Cureus. 2024 Oct 12;16(10):e71293. doi: 10.7759/cureus.71293. eCollection 2024 Oct.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 577 nm Diode laser in people with Acne, run by Al-Azhar 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of comedones, measured through clinical assessment before and after treatment (time frame: 3 months). 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 NCT06909344, which also lists 4 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 18 Aug 2026.