Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids
NCT ID: NCT04237324
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2018-01-01
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NAFL group
One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel).
Treatment one side BLE by NAFL
One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
FMR group
Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
Treatment another side BLE by FMR
One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
Interventions
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Treatment one side BLE by NAFL
One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
Treatment another side BLE by FMR
One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
Eligibility Criteria
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Inclusion Criteria
2. Two senior attending surgeons diagnosed the BLEs;
3. The clinical diagnosis standard was mild swelling or puffiness under the eyes;
4. Between 18 to 60 years old.
Exclusion Criteria
2. History of hormone use;
3. History of keloids;
4. History of injection of botulinum toxin or filler at the site of treatment;
5. Skin inflammation or facial infection;
6. Pregnancy or lactation.
18 Years
60 Years
ALL
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Xianjie Ma, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Plastic Surgery,Xijing Hospital
Locations
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Department of Plastic Surgery, Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Camirand A, Doucet J, Harris J. Anatomy, pathophysiology, and prevention of senile enophthalmia and associated herniated lower eyelid fat pads. Plast Reconstr Surg. 1997 Nov;100(6):1535-46. doi: 10.1097/00006534-199711000-00026.
Goldberg RA, McCann JD, Fiaschetti D, Ben Simon GJ. What causes eyelid bags? Analysis of 114 consecutive patients. Plast Reconstr Surg. 2005 Apr 15;115(5):1395-402; discussion 1403-4. doi: 10.1097/01.prs.0000157016.49072.61.
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Manuskiatti W, Pattanaprichakul P, Inthasotti S, Sitthinamsuwan P, Hanamornroongruang S, Wanitphakdeedecha R, Chu-Ongsakol S. Thermal Response of In Vivo Human Skin to Fractional Radiofrequency Microneedle Device. Biomed Res Int. 2016;2016:6939018. doi: 10.1155/2016/6939018. Epub 2016 May 9.
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Guertler A, Reinholz M, Steckmeier S, Gauglitz GG. Evaluation of a non-ablative, fractional 1565 nm laser for the improvement of striae distensae albae. J Eur Acad Dermatol Venereol. 2019 Jan;33(1):220-226. doi: 10.1111/jdv.15228. Epub 2018 Oct 8.
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Dou W, Yang Q, Yin Y, Fan X, Qiu L, Yang Z, Jian Z, Song W, Ma X. A randomized, split-face controlled trial on the safety and effects of microneedle fractional radiofrequency and fractional erbium-doped glass 1,565-nm laser therapies for baggy lower eyelids. J Cosmet Laser Ther. 2021 Aug;23(5-6):105-112. doi: 10.1080/14764172.2021.2001532. Epub 2021 Nov 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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No.KY20172045-C-1
Identifier Type: -
Identifier Source: org_study_id
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