Evaluation of the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch via a double-blind, placebo-controlled clinical study

C. Lee, H. Yang, S. Kim, M. Kim, H. Kang, N. Kim, S. An, J. Koh, H. Jung

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Objective: Although an ascorbic acid-loaded dissolving microneedle patch has been developed to improve anti-wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch was evaluated in a double-blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid-loaded dissolving microneedle patch was performed. Methods: Twenty-three subjects were selected for anti-wrinkle effect evaluation in a double-blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid-loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid-loaded dissolving microneedle patch and control sample were evaluated. Results: Skin treated with the ascorbic acid-loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values (P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement (P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid-loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization. Conclusions: An ascorbic acid-loaded dissolving microneedle patch produced a significant anti-wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti-wrinkle cosmetic field with patient convenience.

Original languageEnglish
Pages (from-to)375-381
Number of pages7
JournalInternational Journal of Cosmetic Science
Volume38
Issue number4
DOIs
Publication statusPublished - 2016 Aug 1

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Ascorbic acid
Ascorbic Acid
Skin
Placebos
Crows
Double-Blind Method
Cosmetics
Foot
Clinical Studies
Skin effect
Control Groups
Inspection
Surface roughness

All Science Journal Classification (ASJC) codes

  • Chemistry (miscellaneous)
  • Ageing
  • Pharmaceutical Science
  • Drug Discovery
  • Dermatology
  • Colloid and Surface Chemistry

Cite this

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title = "Evaluation of the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch via a double-blind, placebo-controlled clinical study",
abstract = "Objective: Although an ascorbic acid-loaded dissolving microneedle patch has been developed to improve anti-wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch was evaluated in a double-blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid-loaded dissolving microneedle patch was performed. Methods: Twenty-three subjects were selected for anti-wrinkle effect evaluation in a double-blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid-loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid-loaded dissolving microneedle patch and control sample were evaluated. Results: Skin treated with the ascorbic acid-loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values (P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement (P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid-loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization. Conclusions: An ascorbic acid-loaded dissolving microneedle patch produced a significant anti-wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti-wrinkle cosmetic field with patient convenience.",
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Evaluation of the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch via a double-blind, placebo-controlled clinical study. / Lee, C.; Yang, H.; Kim, S.; Kim, M.; Kang, H.; Kim, N.; An, S.; Koh, J.; Jung, H.

In: International Journal of Cosmetic Science, Vol. 38, No. 4, 01.08.2016, p. 375-381.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Evaluation of the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch via a double-blind, placebo-controlled clinical study

AU - Lee, C.

AU - Yang, H.

AU - Kim, S.

AU - Kim, M.

AU - Kang, H.

AU - Kim, N.

AU - An, S.

AU - Koh, J.

AU - Jung, H.

PY - 2016/8/1

Y1 - 2016/8/1

N2 - Objective: Although an ascorbic acid-loaded dissolving microneedle patch has been developed to improve anti-wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch was evaluated in a double-blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid-loaded dissolving microneedle patch was performed. Methods: Twenty-three subjects were selected for anti-wrinkle effect evaluation in a double-blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid-loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid-loaded dissolving microneedle patch and control sample were evaluated. Results: Skin treated with the ascorbic acid-loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values (P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement (P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid-loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization. Conclusions: An ascorbic acid-loaded dissolving microneedle patch produced a significant anti-wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti-wrinkle cosmetic field with patient convenience.

AB - Objective: Although an ascorbic acid-loaded dissolving microneedle patch has been developed to improve anti-wrinkle effects, an efficacy evaluation with a control group has not yet been performed. In this study, the anti-wrinkle effect of an ascorbic acid-loaded dissolving microneedle patch was evaluated in a double-blind clinical study with a control group. In addition, a cumulative skin irritation and sensitization potential of the ascorbic acid-loaded dissolving microneedle patch was performed. Methods: Twenty-three subjects were selected for anti-wrinkle effect evaluation in a double-blind clinical study. Subjects were divided into two groups. Group I subjects applied an ascorbic acid-loaded dissolving microneedle patch on a crow's feet area on the left side of the face and a control sample on a crow's feet area on the right side of the face every 4 days. Group II subjects placed the same patches on opposite sides of the face. Global Photodamage Score and skin replica analysis were conducted by visual inspection and skin visiometer, respectively. A skin irritation and sensitization assessment was performed on 51 subjects using the modified Shelanski & Shelanski procedure. Cumulative skin irritation potential and skin sensitization of the ascorbic acid-loaded dissolving microneedle patch and control sample were evaluated. Results: Skin treated with the ascorbic acid-loaded dissolving microneedle patch showed a statistically significant improvement in both the Global Photodamage Score and visiometer R values (P < 0.05) compared with the control sample. The R2 value (maximum roughness), in particular, showed a highly significant improvement (P < 0.01). The skin irritation and sensitization assessment demonstrated that the ascorbic acid-loaded dissolving microneedle patch did not induce any cumulative skin irritation potential or skin sensitization. Conclusions: An ascorbic acid-loaded dissolving microneedle patch produced a significant anti-wrinkle effect without skin irritation and sensitization problems. This cosmetic dissolving microneedle patch can be used efficiently in the anti-wrinkle cosmetic field with patient convenience.

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