Clinical study to evaluate the efficacy and safety of home-used LED and IRED mask for crow's feet: A multi-center, randomized, double-blind, sham-controlled study.
Level 2 - randomized trial
Multi-center, randomized, double-blind, sham-controlled trial
PubMed 39960921 · doi:10.1097/MD.0000000000041596
What was done
A multi-center, randomized, double-blind, sham-controlled trial was conducted across 2 institutions in 60 Asian participants aged 30 to 65 years with Fitzpatrick skin types II to V and resting crow's feet grading scale (CFGS) scores of 2 to 4. Participants used either an experimental mask combining 630 nm LED and 850 nm IRED light therapy (both max 10 mW/cm³) or a sham control device for 16 weeks. Efficacy was measured at 8, 12, and 16 weeks using CFGS scores from independent raters and investigators, alongside Global Aesthetic Improvement Scale evaluations.
What was found
Independent rater evaluations showed an improvement rate of 86.2% (full analysis set, FAS) and 89.3% (per-protocol set, PPS) in the active treatment group, representing a difference from the sham control group of 69.5% (FAS) and 72.6% (PPS). Changes in CFGS scores from baseline were significantly greater in the active device group than the sham control at 8, 12, and 16 weeks according to both independent raters and investigators.
Why it matters
This study provides sham-controlled evidence that a dual-wavelength (630 nm and 850 nm) home-use light therapy mask can improve periorbital wrinkle appearance over 16 weeks of use.
Limits
The sample size was small (n = 60) and restricted entirely to Asian individuals with Fitzpatrick skin types II to V, limiting generalizability to other populations and skin tones. The abstract does not provide exact numerical CFGS point scores, standard deviations, confidence intervals, p-values, or detailed adverse event counts, and durability of effect post-treatment was not assessed.