Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAFL group | Experimental | One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel). |
|
| FMR group | Active Comparator | Another side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjie Dou, bachelor | Contact | +8602984775306 | 790623705@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xianjie Ma, Ph.D | Department of Plastic Surgery,Xijing Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic Surgery, Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3526832 | Result | 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. | |
| 9385969 | 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. |
Not provided
Not provided
Individual participant data (IPD) will not be shared for patient privacy
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2017 | Dec 19, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2017 | Dec 19, 2019 | ICF_001.pdf |
Not provided
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).
Not provided
Not provided
Not provided
| Treatment another side BLE by FMR | Procedure | One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea). |
|
| 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. |
| 15809605 | 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. |
| 850700 | Result | Castanares S. Classification of baggy eyelids deformity. Plast Reconstr Surg. 1977 May;59(5):629-33. No abstract available. |
| 1852813 | Result | Zarem HA, Resnick JI. Expanded applications for transconjunctival lower lid blepharoplasty. Plast Reconstr Surg. 1991 Aug;88(2):215-20; discussion 221. |
| 9507800 | Result | Roberts TL 3rd. Laser blepharoplasty and laser resurfacing of the periorbital area. Clin Plast Surg. 1998 Jan;25(1):95-108. |
| 19328157 | 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. |
| 19931691 | 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. |
| 10735944 | 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. |
| 15216537 | 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. |
| 27594273 | 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. |
| 25151912 | 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. |
| 26415023 | 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. |
| 26272454 | 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. |
| 27247943 | 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. |
| 22936274 | 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. |
| 24301245 | 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. |
| 25899885 | 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. |
| 24280617 | 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. |
| 25865925 | 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. |
| 23368685 | 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. |
|
| 25560082 | 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. |
| 19143021 | 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. |
| 21763995 | 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. |
| 25810322 | 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. |
| 14571447 | 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. |
| 30169914 | 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. |
| 30895705 | 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. |
| 29080008 | 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. |
| 28585335 | 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. |
| 34812096 | Derived | 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. |