Clinical trial NCT06909344: 577-nm Diode Laser in the Treatment of Non -Inflammatory Acne
Official title: Effectiveness and Safety of 577-nm Diode Laser in the Treatment of Non -Inflammatory Acne
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acne
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with acne comedones
* Patients' ages range from 18-40 years.
* Minimum 10 comedonal lesions on both half of the face

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Reduction in the number of comedones, measured through clinical assessment before and after treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Azhar Assuit university hospital
Study officials:
References:
citation: 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.
citation: Mavranezouli 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.
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citation: Alsohaimi 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.