Correcting Nasojugal Groove with Autologous Cultured Fibroblast Injection: A Pilot Study

Kyung Chul Moon, Hyun Su Lee, Seung-Kyu Han, Ho Yun Chung

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: A new commercial drug that contains autologous cultured fibroblasts has been developed and approved by the United States Food and Drug Administration for improving the appearance of nasolabial folds. However, the treatment requires three sessions every 3–6 weeks. It is known that the skin overlying the nasojugal groove is thinner, and the wrinkle is generally shallower than nasolabial folds. Therefore, we hypothesized that the nasojugal groove could be improved by just one treatment session. Therefore, the purpose of this study was to evaluate the efficacy and safety of autologous cultured fibroblast injection to correct nasojugal grooves. Methods: Forty-six subjects with nasojugal grooves were enrolled in this study. They were injected with autologous cultured fibroblasts or placebo in one session. Blinded evaluators and subjects assessed the efficacy using a validated wrinkle assessment scale at 4, 12, and 24 weeks after the injection. Information of adverse events was collected at each visit. Results: Based on the evaluators’ assessment at 24 weeks after the injection, 76% of subjects treated with autologous cultured fibroblasts showed improvement whereas 0% of subjects treated with placebo showed improvement (P < 0.0001). Based on self-assessment at 24 weeks after the injection, 72% of subjects treated with autologous cultured fibroblasts and 45% of subjects treated with placebo showed improvement (P = 0.0662). There were no serious adverse events related to autologous cultured fibroblast injection. Conclusions: Autologous cultured fibroblast injection might be effective and safe to correct nasojugal grooves. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalAesthetic Plastic Surgery
DOIs
Publication statusAccepted/In press - 2017 Dec 22

Fingerprint

Fibroblasts
Injections
Nasolabial Fold
Placebos
Evidence-Based Medicine
United States Food and Drug Administration
Safety
Skin
Therapeutics
Pharmaceutical Preparations

Keywords

  • Autologous cultured fibroblasts
  • Fibroblast
  • Nasojugal groove
  • Tear trough deformity

ASJC Scopus subject areas

  • Surgery

Cite this

Correcting Nasojugal Groove with Autologous Cultured Fibroblast Injection : A Pilot Study. / Moon, Kyung Chul; Lee, Hyun Su; Han, Seung-Kyu; Chung, Ho Yun.

In: Aesthetic Plastic Surgery, 22.12.2017, p. 1-10.

Research output: Contribution to journalArticle

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abstract = "Background: A new commercial drug that contains autologous cultured fibroblasts has been developed and approved by the United States Food and Drug Administration for improving the appearance of nasolabial folds. However, the treatment requires three sessions every 3–6 weeks. It is known that the skin overlying the nasojugal groove is thinner, and the wrinkle is generally shallower than nasolabial folds. Therefore, we hypothesized that the nasojugal groove could be improved by just one treatment session. Therefore, the purpose of this study was to evaluate the efficacy and safety of autologous cultured fibroblast injection to correct nasojugal grooves. Methods: Forty-six subjects with nasojugal grooves were enrolled in this study. They were injected with autologous cultured fibroblasts or placebo in one session. Blinded evaluators and subjects assessed the efficacy using a validated wrinkle assessment scale at 4, 12, and 24 weeks after the injection. Information of adverse events was collected at each visit. Results: Based on the evaluators’ assessment at 24 weeks after the injection, 76{\%} of subjects treated with autologous cultured fibroblasts showed improvement whereas 0{\%} of subjects treated with placebo showed improvement (P < 0.0001). Based on self-assessment at 24 weeks after the injection, 72{\%} of subjects treated with autologous cultured fibroblasts and 45{\%} of subjects treated with placebo showed improvement (P = 0.0662). There were no serious adverse events related to autologous cultured fibroblast injection. Conclusions: Autologous cultured fibroblast injection might be effective and safe to correct nasojugal grooves. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.",
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AB - Background: A new commercial drug that contains autologous cultured fibroblasts has been developed and approved by the United States Food and Drug Administration for improving the appearance of nasolabial folds. However, the treatment requires three sessions every 3–6 weeks. It is known that the skin overlying the nasojugal groove is thinner, and the wrinkle is generally shallower than nasolabial folds. Therefore, we hypothesized that the nasojugal groove could be improved by just one treatment session. Therefore, the purpose of this study was to evaluate the efficacy and safety of autologous cultured fibroblast injection to correct nasojugal grooves. Methods: Forty-six subjects with nasojugal grooves were enrolled in this study. They were injected with autologous cultured fibroblasts or placebo in one session. Blinded evaluators and subjects assessed the efficacy using a validated wrinkle assessment scale at 4, 12, and 24 weeks after the injection. Information of adverse events was collected at each visit. Results: Based on the evaluators’ assessment at 24 weeks after the injection, 76% of subjects treated with autologous cultured fibroblasts showed improvement whereas 0% of subjects treated with placebo showed improvement (P < 0.0001). Based on self-assessment at 24 weeks after the injection, 72% of subjects treated with autologous cultured fibroblasts and 45% of subjects treated with placebo showed improvement (P = 0.0662). There were no serious adverse events related to autologous cultured fibroblast injection. Conclusions: Autologous cultured fibroblast injection might be effective and safe to correct nasojugal grooves. Level of Evidence IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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