Sponsor study identifier
interventional
26
1 country
1
Study Start
January 17, 2025
Actual (reported)Primary Completion
May 20, 2025
Actual (reported)Study Completion
May 20, 2025
Actual (reported)Acne vulgaris is a common chronic dermatological condition, affecting approximately 85% of adolescents worldwide and ranking eighth among all chronic diseases. Its exacerbation is often associated with recurrent lesions, inadequate treatment, and poor skincare habits such as squeezing or scratching, which frequently lead to the development of post-acne erythema (PAE). PAE is a vascular lesion located beneath the surface of the skin, characterized by a red appearance due to the clustering of dilated capillaries. Although PAE typically improves within 2 to 6 months, it may persist longer in some cases and even result in post-inflammatory hyperpigmentation. This is particularly prevalent in individuals with darker skin tones, where the incidence of PAE and hyperpigmentation ranges from approximately 45.5% to 87.2%. Facial acne not only affects physical appearance but also significantly impairs social interactions and can lead to psychological distress, including low self-esteem and depression. Low-energy, large-spot 1064 nm Nd:YAG laser, which belongs to the near-infrared spectrum, has deeper skin penetration and can effectively target deeper dermal tissues. In the treatment of PAE, the laser energy is absorbed by dilated microvasculature in the skin, promoting vasoconstriction and reducing localized redness and swelling. The low energy setting minimizes thermal damage while stimulating collagen production, thereby enhancing skin repair and improving the appearance of erythema. Delicate Pulsed Light (DPL) operates by emitting pulses of light at specific wavelengths that selectively target skin chromophores. In treating PAE, DPL precisely controls the wavelength and pulse intensity to target dilated blood vessels, thereby alleviating redness and inflammation. Additionally, DPL stimulates the skin's natural repair mechanisms and promotes collagen synthesis, accelerating the resolution of erythema and enhancing overall skin texture. Compared with conventional Intense Pulsed Light (IPL), DPL offers more accurate light modulation, fewer side effects, and better adaptability to various skin types and conditions. In this study, we conducted a split-face randomized controlled trial to compare the clinical efficacy and safety of low-energy large-spot 1064 nm Nd:YAG laser and DPL in treating acne and PAE. We aimed to explore whether there are significant differences between these two modalities in terms of clinical outcomes for post-acne erythema.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 20, 2025
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2025
Actual (reported)May 17, 2025
Actual (reported)May 20, 2025
Actual (reported)May 20, 2025
Actual (reported)May 31, 2025
Actual (reported)PAE lesion count
The post-acne erythema (PAE) lesion count is an important objective indicator for assessing the severity of PAE. It involves recording the number of erythematous lesions on the face to evaluate changes before and after treatment. A higher lesion count indicates more severe erythema and poorer skin recovery. The assessment is typically conducted independently by two trained dermatologists under standardized lighting conditions, with high-resolution imaging systems used when necessary to enhance accuracy and consistency. Care is taken to distinguish PAE from other cutaneous manifestations such as active acne, post-inflammatory hyperpigmentation, and scarring. As a quantitative measure of erythema severity and improvement, the lesion count is widely applied in clinical studies involving light-based and laser therapies.
0, 4, 8, 12 weeks
CEA score
0, 4, 8, 12 weeks
erythema index
0, 4, 8, 12 weeks
GFSS score
0, 4, 8, 12 weeks
The DPL treatment was randomly applied to one side of the face, with an energy density of 6-8 J/cm². Sessions were performed at intervals of 2-3 weeks, for a total of six treatments.
The randomly assigned half of the face received large-spot, low-energy 1064 nm laser treatment at an energy density of 0.8-1 J/cm², performed at intervals of 2-3 weeks for a total of six sessions.
The DPL treatment was randomly applied to one side of the face, with an energy density of 6-8 J/cm². Sessions were performed at intervals of 2-3 weeks, for a total of six treatments..The randomly assigned half of the face received large-spot, low-energy 1064 nm laser treatment at an energy density of 0.8-1 J/cm², performed at intervals of 2-3 weeks for a total of six sessions.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
Wu X, Wang X, Wu X, Cen Q, Xi W, Shang Y, Zhang Z, Lin X. Intense Pulsed Light Therapy Improves Acne-Induced Post-inflammatory Erythema and Hyperpigmentation: A Retrospective Study in Chinese Patients. Dermatol Ther (Heidelb). 2022 May;12(5):1147-1156. doi: 10.1007/s13555-022-00719-9. Epub 2022 Apr 12.
Urban K, Chu S, Giesey RL, Mehrmal S, Uppal P, Delost ME, Delost GR. Burden of skin disease and associated socioeconomic status in Asia: A cross-sectional analysis from the Global Burden of Disease Study 1990-2017. JAAD Int. 2020 Dec 10;2:40-50. doi: 10.1016/j.jdin.2020.10.006. eCollection 2021 Mar.
Weihui zeng
Second Affiliated Hospital of Xi'an Jiaotong University
26 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2025
First Posted
May 31, 2025
Study Start
January 17, 2025
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 20, 2025
Actual (reported)Study Completion
May 20, 2025
Actual (reported)Last Updated
May 31, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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