A phase III, randomized, double-blind, matched-pairs, active-controlled clinical trial and preclinical animal study to compare the durability, efficacy and safety between polynucleotide filler and hyaluronic acid filler in the correction of crow's feet: A new concept of regenerative filler

Chang Sik Pak, Jongho Lee, Hobin Lee, Jaehoon Jeong, Eun Hee Kim, Jinwook Jeong, Hyeyeon Choi, Byunghwi Kim, Sujin Oh, Iksoo Kim, Chanyeong Heo

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

The Rejuran® is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran® on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire®; and Group 3 were treated with Rejuran®. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran® treatment for crow's feet on one side and Yvoire-Hydro® on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran® group showed similar durability and inflammatory response to the Yvoire® group. Upon efficacy assessment, the Rejuran® group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran®, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.

Original languageEnglish
Pages (from-to)S201-S209
JournalJournal of Korean Medical Science
Volume29
DOIs
StatePublished - 1 Jan 2014

Fingerprint

Crows
Polynucleotides
Controlled Clinical Trials
Hyaluronic Acid
Foot
Safety
Clinical Trials
Elasticity
Microscopy
Collagen
Phosphates
Research Personnel
Observation
Outcome Assessment (Health Care)
Staining and Labeling
Skin
Injections
Therapeutics

Keywords

  • Polydeoxyribonucleotides
  • Polynucleotides
  • Rejuvenation
  • Wound healing

Cite this

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title = "A phase III, randomized, double-blind, matched-pairs, active-controlled clinical trial and preclinical animal study to compare the durability, efficacy and safety between polynucleotide filler and hyaluronic acid filler in the correction of crow's feet: A new concept of regenerative filler",
abstract = "The Rejuran{\circledR} is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran{\circledR} on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire{\circledR}; and Group 3 were treated with Rejuran{\circledR}. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran{\circledR} treatment for crow's feet on one side and Yvoire-Hydro{\circledR} on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran{\circledR} group showed similar durability and inflammatory response to the Yvoire{\circledR} group. Upon efficacy assessment, the Rejuran{\circledR} group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran{\circledR}, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.",
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author = "Pak, {Chang Sik} and Jongho Lee and Hobin Lee and Jaehoon Jeong and Kim, {Eun Hee} and Jinwook Jeong and Hyeyeon Choi and Byunghwi Kim and Sujin Oh and Iksoo Kim and Chanyeong Heo",
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T1 - A phase III, randomized, double-blind, matched-pairs, active-controlled clinical trial and preclinical animal study to compare the durability, efficacy and safety between polynucleotide filler and hyaluronic acid filler in the correction of crow's feet

T2 - A new concept of regenerative filler

AU - Pak, Chang Sik

AU - Lee, Jongho

AU - Lee, Hobin

AU - Jeong, Jaehoon

AU - Kim, Eun Hee

AU - Jeong, Jinwook

AU - Choi, Hyeyeon

AU - Kim, Byunghwi

AU - Oh, Sujin

AU - Kim, Iksoo

AU - Heo, Chanyeong

PY - 2014/1/1

Y1 - 2014/1/1

N2 - The Rejuran® is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran® on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire®; and Group 3 were treated with Rejuran®. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran® treatment for crow's feet on one side and Yvoire-Hydro® on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran® group showed similar durability and inflammatory response to the Yvoire® group. Upon efficacy assessment, the Rejuran® group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran®, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.

AB - The Rejuran® is a new filler product made from purified polynucleotides. Here we present data from an animal study and a clinical trial to examine the durability, efficacy and safety of the Rejuran® on crow's feet. For the animal study, 25 mice were divided into three groups: Group 1 received phosphate buffered saline (PBS); Group 2 were treated with Yvoire®; and Group 3 were treated with Rejuran®. The durability and efficacy of each treatment were assessed by microscopy and staining. In the clinical trial, 72 patients were randomized to receive Rejuran® treatment for crow's feet on one side and Yvoire-Hydro® on the contralateral side, at a ratio of 1:1. Repeated treatments were performed every two weeks for a total of three times, over a total of 12 weeks' observation. All injections and observations of efficacy and safety were performed by the same two investigators. In the animal study, the Rejuran® group showed similar durability and inflammatory response to the Yvoire® group. Upon efficacy assessment, the Rejuran® group showed the greatest elasticity and collagen composition, and a significant difference in skin surface roughness and wrinkle depth. In the clinical trial, the primary and secondary objective efficacy outcome measure showed no statistical significance between the two groups, and in safety outcomes there were no unexpected adverse effects. Our data suggest that the Rejuran®, as a new regenerative filler, can be useful to reduce wrinkles, by showing evidence for its efficacy and safety.

KW - Polydeoxyribonucleotides

KW - Polynucleotides

KW - Rejuvenation

KW - Wound healing

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VL - 29

SP - S201-S209

JO - Journal of Korean medical science

JF - Journal of Korean medical science

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