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

Photoaging Clinical Trial

Official title:

A Prospective, Randomized Controlled Split-face Trial of a Fractional Microneedle Radiofrequency Device（FMR） and Fractional Erbium-Doped Glass 1,565-nm Device(NAFL) Therapy in Baggy Lower Eyelids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237324
• Other study ID #: No.KY20172045-C-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: November 2019
• Source: Xijing Hospital
• Contact: Wenjie Dou, bachelor
• Phone: +8602984775306
• Email: 790623705[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Fifteen baggy lower eyelids(BLEs) volunteers were recruited prospectively. Everyone was divided into two groups with FMR and NAFL according to the random number table. One side of the face was treated with FMR device and the other side was treated with NAFL device. Subjective and objective adverse reactions were recorded during the operation. Subjective adverse reactions were recorded after each treatment. The VAS score of patient satisfaction and the blind method score of standard photo observer were used for subjective evaluation, and the objective evaluation was carried out by using VISIA，Antera-3D and CineScan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients with Bags lower eyelids ( BLEs );

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:

1. History of retinoic acid;

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.

Related Conditions & MeSH terms

• Photoaging

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
China	Department of Plastic Surgery, Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (30)

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. — View Citation

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. Review. — View Citation

Castañares S. Classification of baggy eyelids deformity. Plast Reconstr Surg. 1977 May;59(5):629-33. — View Citation

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):1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2016 Oct — View Citation

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. — View Citation

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. — View Citation

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(®) from Canfield vs the ANTERA 3D(®) CS from Miravex. Skin Res Technol. 2018 Feb;24(1):3-8. doi: 10.1111/srt.12381. Epub — View Citation

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. — View Citation

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: 1 — View Citation

McCrudden MT, McAlister E, Courtenay AJ, González-Vázquez 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Sachs ME, Bosniak SL. Correction of true periorbital fat herniation in cosmetic lower lid blepharoplasty. Aesthetic Plast Surg. 1986;10(2):111-4. — View Citation

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): — View Citation

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. — View Citation

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/l — View Citation

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 — View Citation

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

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.