RETRACTED: A Randomized, Participant‐ and Evaluator‐Blinded, Matched‐Pair, Prospective Study Comparing the Safety and Efficacy Between Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet
Open accessAbstract
Background: Dermal fillers have gained widespread popularity for facial cosmetic enhancement and anti‐aging treatments. Recently, polycaprolactone (PCL) and polynucleotides (PN) fillers have emerged as promising options owing to their safety and long‐lasting effects. Objectives: This study aimed to compare the efficacy and safety of a novel PCL‐based dermal filler (DLMR01) with purified PN filler (RJR: Rejuran) in correcting crow's feet wrinkles. Materials and Methods: A randomized, evaluator‐blinded, prospective split‐face study was conducted with 218 healthy Asian participants. The primary outcome was in the improvement rate of the Crow's Feet Grading Scale (CFGS) at rest after 12 weeks. Secondary outcomes included the improvement rate of the CFGS at expression and rest at earlier time points, changes in CFGS, and the Global Aesthetic Improvement Scale (GAIS) assessment. Results: The results showed that DLMR01 was not inferior to RJR in improving crow's feet wrinkles, with a significantly higher CGFS improvement rate at week 12. Both fillers demonstrated good safety profiles, with mild and tolerable adverse events. No serious adverse events were reported during the study period. Conclusion: DLMR01, a PCL‐based dermal filler, showed effectiveness and safety in improving wrinkles described as crow's feet. The study suggests that DLMR01 could be a promising option for noninvasive anti‐aging treatments.
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In South Korea, PN-based injectable products are regulated as medical devices.
“In South Korea, PN-based injectable products are regulated as medical devices [153,154,172].”
From Comparison of Polynucleotide and Polydeoxyribonucleotide in Dermatology: Molecular Mechanisms and Clinical Perspectives (2025) · cites this paper as [172]
The Treatment section describes PN-based Rejuran as the trial’s “control device,” and the Study Design section places the trial in Seoul, Korea. The paper does not state that South Korean regulations classify PN-based injectable products generally as medical devices. (LLM, conf=0.82)
Experimental — accuracy not yet measuredDespite limited sample size in some reported studies, PN treatment has yielded improvements in facial fine lines, overall skin texture, wrinkles, and tone.
“Despite the limited sample size in some reported studies, PN treatment has also yielded improvements in facial fine lines, overall skin texture, wrinkles, and tone [15,153,171,172].”
From Comparison of Polynucleotide and Polydeoxyribonucleotide in Dermatology: Molecular Mechanisms and Clinical Perspectives (2025) · cites this paper as [172]
The Results (Secondary Outcome, Table 1; page unavailable) show lower crow’s-feet wrinkle scores after PN treatment, supporting improvement in wrinkles. The Clinical Assessment section measures crow’s-feet wrinkles and global aesthetic improvement, but does not establish improvements in overall skin texture or tone; it also does not separately demonstrate improvement in facial fine lines. (LLM, conf=0.87)
Experimental — accuracy not yet measured
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Research works printed but not linked: 12
- [1]T. Lombardi, J. Samson, F. Plantier, C. Husson, and R. Kuffer, “ Orofacial Granulomas After Injection of Cosmetic Fillers. Histopathologic and Clinical Study of 11 Cases,” Journal of Oral Pathology & Medicine 33, no. 2 (2004): 115– 120, 10.1111/j.1600-0714.2004.00194.x. 14720198 · DOI
- [2]H. Galadari, D. van Abel, K. Al Nuami, F. Al Faresi, and I. Galadari, “ A Randomized, Prospective, Blinded, Split‐Face, Single‐Center Study Comparing Polycaprolactone to Hyaluronic Acid for Treatment of Nasolabial Folds,” Journal of Cosmetic Dermatology 14, no. 1 (2015): 27– 32, 10.1111/jocd.12126. 25564797 · DOI
- [3]M. M. Moers‐Carpi and S. Sherwood, “ Polycaprolactone for the Correction of Nasolabial Folds: A 24‐Month, Prospective, Randomized, Controlled Clinical Trial,” Dermatologic Surgery 39, no. 3 Pt 1 (2013): 457– 463, 10.1111/dsu.12054. 23350617 PMC3615178 · DOI
- [4]V. R. Sinha, K. Bansal, R. Kaushik, R. Kumria, and A. Trehan, “ Poly‐Epsilon‐Caprolactone Microspheres and Nanospheres: An Overview,” International Journal of Pharmaceutics 278, no. 1 (2004): 1– 23, 10.1016/j.ijpharm.2004.01.044. 15158945 · DOI
- [5]V. M. Figueiredo, “ A Five‐Patient Prospective Pilot Study of a Polycaprolactone Based Dermal Filler for Hand Rejuvenation,” Journal of Cosmetic Dermatology 12, no. 1 (2013): 73– 77, 10.1111/jocd.12020. 23438145 · DOI
- [6]Y. J. Lee, H. T. Kim, Y. J. Lee, et al., “ Comparison of the Effects of Polynucleotide and Hyaluronic Acid Fillers on Periocular Rejuvenation: A Randomized, Double‐Blind, Split‐Face Trial,” Journal of Dermatological Treatment 33, no. 1 (2022): 254– 260, 10.1080/09546634.2020.1748857. 32248707 · DOI
- [7]G. J. Jeong, G. R. Ahn, S. J. Park, J. Y. Hong, and B. J. Kim, “ A Randomized, Patient/Evaluator‐Blinded, Split‐Face Study to Compare the Efficacy and Safety of Polycaprolactone and Polynucleotide Fillers in the Correction of Crow's Feet: The Latest Biostimulatory Dermal Filler for Crow's Feet,” Journal of Cosmetic Dermatology 19, no. 7 (2020): 1593– 1599, 10.1111/jocd.13199. 31680395 · DOI
- [8]M. Moers‐Carpi, M. O. Christen, H. Delmar, P. Brun, I. Bodokh, and P. Kestemont, “ European Multicenter Prospective Study Evaluating Long‐Term Safety and Efficacy of the Polycaprolactone‐Based Dermal Filler in Nasolabial Fold Correction,” Dermatologic Surgery 47, no. 7 (2021): 960– 965, 10.1097/DSS.0000000000002978. 33731572 · DOI
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- [10]J. A. Kim and D. Van Abel, “ Neocollagenesis in Human Tissue Injected With a Polycaprolactone‐Based Dermal Filler,” Journal of Cosmetic and Laser Therapy 17 (2015): 99– 101, 10.3109/14764172.2014.968586. 25260139 · DOI
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- [12]K. Y. Park, J. Seok, N. K. Rho, B. J. Kim, and M. N. Kim, “ Long‐Chain Polynucleotide Filler for Skin Rejuvenation: Efficacy and Complications in Five Patients,” Dermatologic Therapy 29, no. 1 (2016): 37– 40, 10.1111/dth.12299. 26814448 · DOI · Paper page
Cited by
Sorted by citations
Kim, S. T. (2025) · Pharmaceutics · doi:10.3390/pharmaceutics17081024 · Cited by 18 · see citing works
- Authors
- Choi, S. Y., Koh, Y. G., Yoo, K. H., Han, H. S., Seok, J., & Kim, B. J.
- Affiliations
- Chung-Ang University Gwangmyeong Hospital (KR)
- Chung-Ang University Hospital (KR)
- Corresponding author
- Kim, Beom Joon
- Venue
- Journal of Cosmetic Dermatology
- Publisher
- Wiley
- Published
- 2024-09-23
- Volume
- 24
- Issue
- 1
- Pages
- e16576-e16576
- ISSN
- 1473-2130 (ISSN-L)
- 1473-2165
- PMC
- PMC11754925
- OpenAlex
- W4402782971
- Cited by
- 8
- References
- 0
- Citations by year
- 2026: 5 · 2025: 3
- FWCI
- 3.24
- Type
- journal article
- Language
- en
- Status
- Retracted
- Update notices
- retraction (2026-03-16)
- Open access
- hybrid
- doi.org
- Locations
- Journal of Cosmetic Dermatology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Chung-Ang University
- Topics
- Health Sciences › Medicine › Dermatology › Facial Rejuvenation and Surgery Techniques
- Health Sciences › Medicine › Dermatology › Dermatologic Treatments and Research
- Health Sciences › Medicine › Neurology › Facial Nerve Paralysis Treatment and Research
- Keywords
- polycaprolactone, crow's feet, facial wrinkles, dermal fillers, anti-aging therapy, cosmetic safety, split-face study
- MeSH terms
- Dermal Fillers, Adult, Cosmetic Techniques, Female, Foot, Humans, Male, Middle Aged, Polyesters, Polynucleotides, Prospective Studies, Rejuvenation, Skin Aging, Single-Blind Method, Treatment Outcome
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