Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids

NCT04237324 | Unknown

• 1 other identifier: No.KY20172045-C-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)

Conditions

Photoaging

Outcome Measures

Primary Outcomes (5)

• Patient Satisfaction Scores(PSS)

  Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied)

  Change from Baseline PSS at 1-month after 3rd treatment, Change from Baseline PSS at 3-month after 3rd treatment, Change from 1-month after 3rd treatment PSS at 3-month after 3rd treatment.

• Blinded Investigator Assesement(BIA)

  The physician's severity score of standard photographs used VAS 0-4(VAS, 0 = no eyelid bags, 4= very obvious eyelid bags)

  Change from Baseline BIA at 1-month after 3rd treatment, Change from Baseline BIA at 3-month after 3rd treatment, Change from 1-month after 3rd treatment BIA at 3-month after 3rd treatment.

• Periorbital wrinkles assessment by VISIA system(VISIA)

  VISIA Complexion Analysis System (Canfield Imaging Systems, Fairfield, New Jersey, USA)

  Change from Baseline VISIA at 1-month after 3rd treatment, Change from Baseline VISIA at 3-month after 3rd treatment, Change from 1-month after 3rd treatment VISIA at 3-month after 3rd treatment.

• Change of BLEs by ANTERA-3D(ANTERA-3D)

  volume of elevations (mm3), elevation area (mm2), and the maximum peak height volume of elevations (mm3), elevation area (mm2), and the maximum peak height We assessment the volume(mm3), elevation area (mm2), and the maximum peak height (mm) of elevations(mm) by ANRERA-3D camera (Miravex Limited, Ireland).

  Change from Baseline ANTERA-3D at 1-month after 3rd treatment, Change from Baseline ANTERA-3D at 3-month after 3rd treatment, Change from 1-month after 3rd treatment ANTERA-3D at 3-month after 3rd treatment.

• Orbital fat depth and length by CineScan assessment(CineScan)

  Orbital fat depth(mm) and length(mm) by CineScan Ultrasonic Ophthalmic A and B scan System (Quantel Medical Inc., Bozeman, Montana, USA).

  Change from Baseline CineScan at 1-month after 3rd treatment, Change from Baseline CineScan at 3-month after 3rd treatment, Change from 1-month after 3rd treatment CineScan at 3-month after 3rd treatment.

Study Arms (2)

NAFL group

EXPERIMENTAL

One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel).

Procedure: Treatment one side BLE by NAFL

FMR group

ACTIVE COMPARATOR

Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

Procedure: Treatment another side BLE by FMR

Interventions

Treatment one side BLE by NAFL PROCEDURE

One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.

NAFL group

Treatment another side BLE by FMR PROCEDURE

One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).

FMR group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Bags lower eyelids ( BLEs )；
• Two senior attending surgeons diagnosed the BLEs;
• The clinical diagnosis standard was mild swelling or puffiness under the eyes;
• Between 18 to 60 years old.

You may not qualify if:

• History of retinoic acid;
• History of hormone use;
• History of keloids;
• History of injection of botulinum toxin or filler at the site of treatment;
• Skin inflammation or facial infection;
• Pregnancy or lactation.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Plastic Surgery, Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (31)

• Sachs ME, Bosniak SL. Correction of true periorbital fat herniation in cosmetic lower lid blepharoplasty. Aesthetic Plast Surg. 1986;10(2):111-4. doi: 10.1007/BF01575278.

  PMID: 3526832 RESULT

• 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.

  PMID: 9385969 RESULT

• 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.

  PMID: 15809605 RESULT

• Castanares S. Classification of baggy eyelids deformity. Plast Reconstr Surg. 1977 May;59(5):629-33. No abstract available.

  PMID: 850700 RESULT

• Zarem HA, Resnick JI. Expanded applications for transconjunctival lower lid blepharoplasty. Plast Reconstr Surg. 1991 Aug;88(2):215-20; discussion 221.

  PMID: 1852813 RESULT

• Roberts TL 3rd. Laser blepharoplasty and laser resurfacing of the periorbital area. Clin Plast Surg. 1998 Jan;25(1):95-108.

  PMID: 9507800 RESULT

• Roberts TL 3rd, Yokoo KM. In pursuit of optimal periorbital rejuvenation: laser resurfacing with or without blepharoplasty and brow lift. Aesthet Surg J. 1998 Sep-Oct;18(5):321-32. doi: 10.1016/s1090-820x(98)70086-x.

  PMID: 19328157 RESULT

• Beylot C, Grognard C, Michaud T. [Ablative and fractional lasers]. Ann Dermatol Venereol. 2009 Oct;136 Suppl 6:S311-9. doi: 10.1016/S0151-9638(09)72539-6. French.

  PMID: 19931691 RESULT

• Jordan R, Cummins C, Burls A. Laser resurfacing of the skin for the improvement of facial acne scarring: a systematic review of the evidence. Br J Dermatol. 2000 Mar;142(3):413-23. doi: 10.1046/j.1365-2133.2000.03350.x.

  PMID: 10735944 RESULT

• Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048.

  PMID: 15216537 RESULT

• Kaplan H, Kaplan L. Combination of microneedle radiofrequency (RF), fractional RF skin resurfacing and multi-source non-ablative skin tightening for minimal-downtime, full-face skin rejuvenation. J Cosmet Laser Ther. 2016 Dec;18(8):438-441. doi: 10.1080/14764172.2016.1228981. Epub 2016 Oct 5.

  PMID: 27594273 RESULT

• Gershonowitz A, Gat A. VoluDerm microneedle technology for skin treatments-in vivo histological evidence. J Cosmet Laser Ther. 2015 Feb;17(1):9-14. doi: 10.3109/14764172.2014.957219. Epub 2014 Sep 25.

  PMID: 25151912 RESULT

• Lee HJ, Seo SR, Yoon MS, Song JY, Lee EY, Lee SE. Microneedle fractional radiofrequency increases epidermal hyaluronan and reverses age-related epidermal dysfunction. Lasers Surg Med. 2016 Feb;48(2):140-9. doi: 10.1002/lsm.22420. Epub 2015 Sep 28.

  PMID: 26415023 RESULT

• Tanaka Y. Long-term three-dimensional volumetric assessment of skin tightening using a sharply tapered non-insulated microneedle radiofrequency applicator with novel fractionated pulse mode in asians. Lasers Surg Med. 2015 Oct;47(8):626-33. doi: 10.1002/lsm.22401. Epub 2015 Aug 14.

  PMID: 26272454 RESULT

• 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.

  PMID: 27247943 RESULT

• Seo KY, Yoon MS, Kim DH, Lee HJ. Skin rejuvenation by microneedle fractional radiofrequency treatment in Asian skin; clinical and histological analysis. Lasers Surg Med. 2012 Oct;44(8):631-6. doi: 10.1002/lsm.22071. Epub 2012 Aug 30.

  PMID: 22936274 RESULT

• Harth Y, Frank I. In vivo histological evaluation of non-insulated microneedle radiofrequency applicator with novel fractionated pulse mode. J Drugs Dermatol. 2013 Dec;12(12):1430-3.

  PMID: 24301245 RESULT

• Lee SJ, Kim JI, Yang YJ, Nam JH, Kim WS. Treatment of periorbital wrinkles with a novel fractional radiofrequency microneedle system in dark-skinned patients. Dermatol Surg. 2015 May;41(5):615-22. doi: 10.1097/DSS.0000000000000216.

  PMID: 25899885 RESULT

• Jeon IK, Chang SE, Park GH, Roh MR. Comparison of microneedle fractional radiofrequency therapy with intradermal botulinum toxin a injection for periorbital rejuvenation. Dermatology. 2013;227(4):367-72. doi: 10.1159/000356162. Epub 2013 Nov 21.

  PMID: 24280617 RESULT

• McCrudden MT, McAlister E, Courtenay AJ, Gonzalez-Vazquez P, Singh TR, Donnelly RF. Microneedle applications in improving skin appearance. Exp Dermatol. 2015 Aug;24(8):561-6. doi: 10.1111/exd.12723. Epub 2015 May 26.

  PMID: 25865925 RESULT

• Seo KY, Kim DH, Lee SE, Yoon MS, Lee HJ. Skin rejuvenation by microneedle fractional radiofrequency and a human stem cell conditioned medium in Asian skin: a randomized controlled investigator blinded split-face study. J Cosmet Laser Ther. 2013 Feb;15(1):25-33. doi: 10.3109/14764172.2012.748201.

  PMID: 23368685 RESULT

• Naouri M, Mazer JM. Non-insulated microneedle fractional radiofrequency for the treatment of scars and photoaging. J Eur Acad Dermatol Venereol. 2016 Mar;30(3):499-502. doi: 10.1111/jdv.12890. Epub 2015 Jan 5. No abstract available.

  PMID: 25560082 RESULT

• Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B. Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis. Lasers Surg Med. 2009 Jan;41(1):1-9. doi: 10.1002/lsm.20731.

  PMID: 19143021 RESULT

• Polder KD, Bruce S. Radiofrequency: Thermage. Facial Plast Surg Clin North Am. 2011 May;19(2):347-59. doi: 10.1016/j.fsc.2011.04.006.

  PMID: 21763995 RESULT

• Chae WS, Seong JY, Jung HN, Kong SH, Kim MH, Suh HS, Choi YS. Comparative study on efficacy and safety of 1550 nm Er:Glass fractional laser and fractional radiofrequency microneedle device for facial atrophic acne scar. J Cosmet Dermatol. 2015 Jun;14(2):100-6. doi: 10.1111/jocd.12139. Epub 2015 Mar 23.

  PMID: 25810322 RESULT

• Fitzpatrick R, Geronemus R, Goldberg D, Kaminer M, Kilmer S, Ruiz-Esparza J. Multicenter study of noninvasive radiofrequency for periorbital tissue tightening. Lasers Surg Med. 2003;33(4):232-42. doi: 10.1002/lsm.10225.

  PMID: 14571447 RESULT

• 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.

  PMID: 30169914 RESULT

• Yang S, Kim BR, Kim HS, Choi CW, Jo SJ, Youn SW. A quantitative, objective method for evaluating the surgical outcomes of baggy eyelid correction using orbital gray scale analysis. J Cosmet Dermatol. 2019 Dec;18(6):1814-1820. doi: 10.1111/jocd.12922. Epub 2019 Mar 20.

  PMID: 30895705 RESULT

• Guertler A, Reinholz M, Poetschke J, Steckmeier S, Schwaiger H, Gauglitz GG. Objective evaluation of the efficacy of a non-ablative fractional 1565 nm laser for the treatment of deliberate self-harm scars. Lasers Med Sci. 2018 Feb;33(2):241-250. doi: 10.1007/s10103-017-2348-x. Epub 2017 Oct 27.

  PMID: 29080008 RESULT

• Linming F, Wei H, Anqi L, Yuanyu C, Heng X, Sushmita P, Yiming L, Li L. Comparison of two skin imaging analysis instruments: The VISIA(R) from Canfield vs the ANTERA 3D(R) CS from Miravex. Skin Res Technol. 2018 Feb;24(1):3-8. doi: 10.1111/srt.12381. Epub 2017 Jun 5.

  PMID: 28585335 RESULT

• 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.

  PMID: 34812096 DERIVED

Study Officials

• Xianjie Ma, Ph.D

  Department of Plastic Surgery,Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Dou, bachelor

CONTACT

+8602984775306; 790623705@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The purpose of this study is to assess the safety and efficacy of FMR and NAFL for the treatment of BLEs in Asian. After being informed about the study and potential risks, all patients giving written informed consent. Patients were randomly divided into FMR side and NAFL opposite side 3 times in total at a 1-month interval. FMR side has been used by FMR device (INFINI, Lutronic Co., Goyang-si, Korea) and the NAFL side has been used by ResurFX module of M22 (Lumenis Co., Yokneam, Israel).

Study Record Dates

• First Submitted: December 24, 2019
• First Posted: January 23, 2020
• Study Start: January 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 23, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)