Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial
Recently, several clinical studies have been conducted using microneedles (MNs), and various devices have been developed. This study aimed to propose and confirm the feasibility of a placebo control for activating MN clinical research. A 0.5 mm MN stamp with 42 needles was used as a treatment interv...
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| Format: | Article |
| Language: | English |
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MDPI AG
2024-03-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/16/3/395 |
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| author | Seung-Yeon Jeong Ye-Seul Lee Ji-Yeun Park Jung-Hwan Park Hi-Joon Park Song-Yi Kim |
| author_facet | Seung-Yeon Jeong Ye-Seul Lee Ji-Yeun Park Jung-Hwan Park Hi-Joon Park Song-Yi Kim |
| author_sort | Seung-Yeon Jeong |
| collection | DOAJ |
| description | Recently, several clinical studies have been conducted using microneedles (MNs), and various devices have been developed. This study aimed to propose and confirm the feasibility of a placebo control for activating MN clinical research. A 0.5 mm MN stamp with 42 needles was used as a treatment intervention, and a placebo stamp with four acupressure-type needles that did not penetrate was proposed and designed as a control for comparison. First, to check whether the placebo stamp did not invade the skin and to set an appropriate level of pressure to be provided during skin stimulation, two participants were stimulated with five different forces on the forearm, and then the skin was dyed. Secondly, to evaluate the validity of the placebo control group, a blinded study between the MN and placebo stamps was performed on 15 participants. We confirmed that the placebo stamp did not penetrate the skin at any intensity or location. Both types of stamps reported relatively low pain levels, but the MN stamp induced higher pain compared to the placebo stamp. Based on the speculation regarding the type of intervention received, the MN stamp was successfully blinded (random guess), whereas the placebo stamp was unblinded. However, according to a subgroup analysis, it was confirmed that the group with low skin sensitivity was completely blind. Blinding the placebo MN stamp had limited success in participants with low skin sensitivity. Future research on suitable placebo controls, considering the variations in MN stamp length and needle count, is warranted. |
| first_indexed | 2024-04-24T17:54:56Z |
| format | Article |
| id | doaj.art-4bd2032c5c5e498db80357fc95be4a34 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-04-24T17:54:56Z |
| publishDate | 2024-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-4bd2032c5c5e498db80357fc95be4a342024-03-27T13:59:48ZengMDPI AGPharmaceutics1999-49232024-03-0116339510.3390/pharmaceutics16030395Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control TrialSeung-Yeon Jeong0Ye-Seul Lee1Ji-Yeun Park2Jung-Hwan Park3Hi-Joon Park4Song-Yi Kim5Department of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam 13120, Republic of KoreaJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul 06110, Republic of KoreaDepartment of Meridian & Acupoint, College of Korean Medicine, Daejeon University, Daejeon 34141, Republic of KoreaDepartment of BioNano Technology, Gachon BioNano Research Institute, Gachon University, Seongnam 13120, Republic of KoreaAcupuncture and Meridian Science Research Center (AMSRC), Kyung Hee University, Dongdaemun-gu, Seoul 02447, Republic of KoreaDepartment of Anatomy and Acupoint, College of Korean Medicine, Gachon University, Seongnam 13120, Republic of KoreaRecently, several clinical studies have been conducted using microneedles (MNs), and various devices have been developed. This study aimed to propose and confirm the feasibility of a placebo control for activating MN clinical research. A 0.5 mm MN stamp with 42 needles was used as a treatment intervention, and a placebo stamp with four acupressure-type needles that did not penetrate was proposed and designed as a control for comparison. First, to check whether the placebo stamp did not invade the skin and to set an appropriate level of pressure to be provided during skin stimulation, two participants were stimulated with five different forces on the forearm, and then the skin was dyed. Secondly, to evaluate the validity of the placebo control group, a blinded study between the MN and placebo stamps was performed on 15 participants. We confirmed that the placebo stamp did not penetrate the skin at any intensity or location. Both types of stamps reported relatively low pain levels, but the MN stamp induced higher pain compared to the placebo stamp. Based on the speculation regarding the type of intervention received, the MN stamp was successfully blinded (random guess), whereas the placebo stamp was unblinded. However, according to a subgroup analysis, it was confirmed that the group with low skin sensitivity was completely blind. Blinding the placebo MN stamp had limited success in participants with low skin sensitivity. Future research on suitable placebo controls, considering the variations in MN stamp length and needle count, is warranted.https://www.mdpi.com/1999-4923/16/3/395microneedlesplacebosham controldrug deliveryacupuncture |
| spellingShingle | Seung-Yeon Jeong Ye-Seul Lee Ji-Yeun Park Jung-Hwan Park Hi-Joon Park Song-Yi Kim Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial Pharmaceutics microneedles placebo sham control drug delivery acupuncture |
| title | Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial |
| title_full | Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial |
| title_fullStr | Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial |
| title_full_unstemmed | Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial |
| title_short | Designing a Placebo Microneedle Stamp: Modeling and Validation in a Clinical Control Trial |
| title_sort | designing a placebo microneedle stamp modeling and validation in a clinical control trial |
| topic | microneedles placebo sham control drug delivery acupuncture |
| url | https://www.mdpi.com/1999-4923/16/3/395 |
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