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Skin Quality and Safety Following Liquid-Form Polycaprolactone for Facial Rejuvenation: A Prospective Single-Arm
Panwadee Thongjaroensirikul1, Rungsima Wanitphakdeedecha2, Pitchaya Maneeprasopchoke1
1Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok, 10700, Thailand.
Introduction:
Prospective human evidence for liquid-form polycaprolactone (PCL) in facial rejuvenation is limited. We evaluated skin-quality changes and adverse events following treatment.
Methods:
Thirty participants received three monthly superficial subcutaneous (clinically intended subdermal) treatments in an uncontrolled prospective study. Skin mechanical, pigmentary, hydration, and sebum measurements were assessed through 6 months. The registered Antera primary outcomes are not included in this focused report. Instrumental measurements were also collected at 9 and 12 months but were excluded after calibration-related reliability concerns were identified during review of the late dataset; an institutional review board amendment subsequently restricted instrumental reporting to 6 months. Analyses used mixed-effects models; the corrected analysis of the delayed-to-immediate deformation ratio (R6) used restricted maximum likelihood and Bonferroni-adjusted baseline comparisons.
Results:
All 30 participants completed treatment; attendance was 29 at 1 month and 28 at 3 and 6 months. Maximum skin deformation (R0) decreased from 0.153 ± 0.062 to 0.112 ± 0.105 mm at 6 months. The delayed-to-immediate deformation ratio (R6) decreased from 0.307 ± 0.307 to 0.174 ± 0.277 (adjusted p = 0.038; overall p = 0.001). Hydration decreased. Bruising, swelling, and persistent postprocedural pain were reported; one swelling event was moderate and the remaining events were mild. All resolved without specific treatment. No serious adverse events were reported in the available safety summary.
Conclusion:
Skin mechanical changes were observed following liquid-form PCL treatment. The uncontrolled design, variability, and retrospective restriction of instrumental reporting limit conclusions about efficacy, mechanism, and long-term durability. Larger controlled studies are needed.
Trial Registration:
Thai Clinical Trials Registry, TCTR20250209003; retrospectively registered on February 9, 2025.