Ethics statement
This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine (approval number: 2024-L086). The trial was registered with the Chinese Clinical Trial Registry (registration number: CTR2400092254). All participants provided written informed consent before enrollment, including consent for standardized facial photography and publication of identifiable clinical facial images; the eyes were mosaicked in the published figures as an additional privacy safeguard. The workflow is depicted in Figure 1. The equipment, devices, and materials used in this protocol are listed in the Table of Materials.
Participant selection and randomization
Participants were recruited from the institutional database of patients seeking facial rejuvenation treatment between January 2024 and June 2024. Inclusion criteria required adults aged 23-55 years with Fitzpatrick skin types II–IV and visible facial photoaging. Exclusion criteria included sun exposure within 4 weeks, photosensitive disease, photosensitizing medication or topical retinoid use within the prior month, active skin infection, inflammatory skin disease, and pregnancy or lactation. To limit post-enrollment confounding by ultraviolet exposure, participants received the same broad-spectrum sunscreen and were instructed to use it daily and avoid new topical active treatments. Twenty-seven eligible participants were randomized to the 80-ms group (n = 13) or 15-ms group (n = 14) using computer-generated permuted blocks of four. Sequentially numbered opaque sealed envelopes maintained allocation concealment until enrollment.
Pre-treatment procedures
All participants underwent standardized facial cleansing without topical anesthesia. After retroauricular test spots were applied, the site was observed for 3–5 min for erythema and pain. Testing began at 32 J/cm2 in the 80-ms group and 22 J/cm2 in the 15-ms group. If only mild transient erythema occurred, with VAS pain ≤ 3 and no blistering or intense whitening, fluence was increased in 2 J/cm2 increments. The highest tolerable fluence producing a mild thermal response without severe pain or immediate adverse effects was used within the respective 32–50 and 22–30 J/cm2 ranges.
IPL treatment parameters and procedure
The study compared two complete IPL treatment regimens that differed in both pulse width and fluence; it was not designed to estimate an isolated pulse-width effect. The 80-ms regimen used 32–50 J/cm2 and the 15-ms regimen used 22–30 J/cm2. Both used a fixed 525-nm long-pass filter (525-1200 nm spectrum), single-pulse mode, a 2-mm layer of clear optical cooling gel, and a single non-overlapping pass with a 12 × 28 mm spot. Integrated synchronous contact sapphire cooling was used throughout. The same senior dermatologist (Y.K.; >5 years of experience with energy-based aesthetic procedures) performed all treatments. Standard post-treatment care included 15 min of cooling and daily broad-spectrum sunscreen.
Skin parameter assessment protocol
To ensure consistency in longitudinal assessment and eliminate evaluation bias, all objective skin parameter measurements and visual documentation were conducted by the same clinical research technician across all participants, who was fully certified in biophysical skin analysis and completely blinded to participants' treatment group assignments.
Biomechanical properties assessment and parameter definitions
Skin elasticity was measured with a 2-mm aperture suction probe at the forehead midline, bilateral zygomatic prominences, and bilateral masseter regions. Ten 1-second suction/1-second relaxation cycles were acquired at 450 mbar; three acquisitions per site were averaged, then the five site means were averaged to obtain one participant-level value per visit. R2 is a unitless gross-elasticity ratio (elastic recovery divided by maximum deformation); higher values indicate greater elasticity. F4 was exported by the device in mm/s and was treated in this study as a viscoelasticity index, with lower values indicating improvement. Analyses used the raw participant-level R2 and F4 values, not percentages.
Sebum production quantification and interpretation
Sebum content was quantified with a photometric sebum cassette probe at the same standardized sites after a 30-second contact. Three readings per site were averaged, then site means were averaged to obtain one participant-level value per visit. Sebum is reported in µg/cm2; lower values indicate less surface sebum. Measurements were performed at 22 ± 2 °C and 50 ± 5% relative humidity.
Standardized imaging and digital facial analysis parameters
Standardized frontal and 33° lateral images were acquired with a multispectral facial complexion analysis system under consistent positioning, lighting, and background conditions. The wrinkle outcome was a device-derived percentile on a 0–100 scale; higher values indicate fewer detected wrinkles. Pore feature count was the number of algorithm-detected pore features in the standardized region; lower values indicate improvement. The same software, capture geometry, and analysis regions were used at every visit. Image analysts were blinded to group assignment.
Anatomical and subcutaneous layer evaluation
To assess individual variation in subcutaneous tissue over bony prominences (maxilla and mandible) relative to deep-tissue sensory responses, soft-tissue thickness at the mid-cheek and lower buccal regions was evaluated during baseline 3D multispectral facial imaging and biophysical assessment. Subcutaneous thickness was estimated at standardized anatomical landmarks based on standardized cross-sectional contour mapping and high-resolution optical surface profilometry integrated into the facial analysis system. All anatomical site measurements were calibrated under standardized room conditions and evaluated by the same blinded technician.
Patient-reported outcome measures
Treatment satisfaction was assessed using a validated 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) at each follow-up visit. Pain intensity during treatment was evaluated using a digital visual analog scale (VAS: 0–10) administered immediately following each treatment session. All patient-reported outcomes were collected using standardized electronic data capture systems operating on a secure institutional database to minimize recording errors.
Safety monitoring and adverse event documentation
A comprehensive safety-monitoring protocol was used throughout the study. Erythema, edema, blistering, pigmentary change, scarring, and transient localized deep-tissue sensitivity/gum soreness were assessed and documented on a standardized adverse-event registration form. Severity, duration, and management were recorded; participants were instructed to report events between visits.
Statistical analysis plan
Analyses included all 27 randomized participants, each with complete observations at six visits. This was an exploratory pilot trial based on clinical feasibility. Continuous outcomes are summarized as mean ± standard deviation. Baseline-to-3-month within-group changes were used in paired t-tests. For each primary objective endpoint, the 3-month ANCOVA included randomized group, the corresponding baseline outcome value, and age (years) as covariates. Model-based adjusted means, standard errors, 95% confidence intervals, and exact two-sided p values are reported; differences are 80 ms minus 15 ms. Holm-Bonferroni correction controlled the family-wise error rate across wrinkle percentile, pore feature count, sebum, R2, and F4. Standardized sunscreen instructions and behavioral restrictions were used to minimize differential sun exposure, but individual ultraviolet exposure was not directly quantified. Change-score analyses were sensitivity analyses; longitudinal patterns used mixed-design repeated-measures analysis of variance with Greenhouse-Geisser correction. Patient-reported outcomes used Welch t-tests and categorical safety outcomes used Fisher exact tests.