PhotoagingNCT04237324
Efficacy of Fractional Microneedle Radiofrequency and Fractional Erbium-Doped Glass 1,565-nm for Baggy Lower Eyelids
A study testing Treatment one side BLE by NAFL and Treatment another side BLE by FMR in people with Photoaging, run by Xijing Hospital at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Photoaging
- What is being tested?
- Treatment one side BLE by NAFL and Treatment another side BLE by FMR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Plastic Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032
Wenjie Dou, Bachelor, 8684775306, 790623705@qq.com
About this study
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
The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)
Read the detailed 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.
- Conditions
- Photoaging
- Being tested
- Treatment one side BLE by NAFL, Treatment another side BLE by FMR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment one side BLE by NAFLProcedure or surgery
One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
Treatment another side BLE by FMRProcedure or surgery
One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
| Study group | Role | What they receive |
|---|---|---|
| NAFL group | Experimental | One side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel). Receives: 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). Receives: Procedure: Treatment another side BLE by FMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Scores(PSS)
Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jan 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianjie Ma, Ph.D, Principal investigator, Department of Plastic Surgery,Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237324
- Sponsor's protocol ID
- No.KY20172045-C-1
- Status last verified
- Nov 2019
- First submitted
- 24 Dec 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for patient privacy
Publications
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.
PubMed 3526832Camirand 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.
PubMed 9385969Goldberg 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.
PubMed 15809605Castanares S. Classification of baggy eyelids deformity. Plast Reconstr Surg. 1977 May;59(5):629-33. No abstract available.
PubMed 850700Zarem HA, Resnick JI. Expanded applications for transconjunctival lower lid blepharoplasty. Plast Reconstr Surg. 1991 Aug;88(2):215-20; discussion 221.
PubMed 1852813Roberts TL 3rd. Laser blepharoplasty and laser resurfacing of the periorbital area. Clin Plast Surg. 1998 Jan;25(1):95-108.
PubMed 9507800Roberts 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.
PubMed 19328157Beylot 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.
PubMed 19931691Jordan 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.
PubMed 10735944Manstein 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.
PubMed 15216537Kaplan 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.
PubMed 27594273Gershonowitz 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.
PubMed 25151912Lee 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.
PubMed 26415023Tanaka 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.
PubMed 26272454Manuskiatti 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.
PubMed 27247943
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04237324
- Acronym / sponsor ID
- No.KY20172045-C-1
- Conditions
- Photoaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the efficacy and safety of FMR and NAFL in the treatment of baggy lower eyelids(BLEs)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| NAFL group | Experimental | Procedure: Treatment one side BLE by NAFLOne side of the patient face has been therapied by 1565nm fiber nonablative fractional laser(Lumenis Co., Yokneam, Israel). |
| FMR group | Active comparator | Procedure: Treatment another side BLE by FMRAnother side of the patient face has been therapied by FMR device (INFINI, Lutronic Co., Goyang-si, Korea). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment one side BLE by NAFLOne side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly. | Procedure or surgery | NAFL group |
| Treatment another side BLE by FMROne side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea). | Procedure or surgery | FMR group |
Primary outcome
Patient Satisfaction Scores(PSS)
Time frame: 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.
Patients scored their satisfaction used 10-point Visual analogue scales (VAS, 0 = unsatisfied, 10= very satisfied)
Blinded Investigator Assesement(BIA)
Time frame: 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.
The physician's severity score of standard photographs used VAS 0-4(VAS, 0 = no eyelid bags, 4= very obvious eyelid bags)
Periorbital wrinkles assessment by VISIA system(VISIA)
Time frame: 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.
VISIA Complexion Analysis System (Canfield Imaging Systems, Fairfield, New Jersey, USA)
Change of BLEs by ANTERA-3D(ANTERA-3D)
Time frame: 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.
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).
Orbital fat depth and length by CineScan assessment(CineScan)
Time frame: 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.
Orbital fat depth(mm) and length(mm) by CineScan Ultrasonic Ophthalmic A and B scan System (Quantel Medical Inc., Bozeman, Montana, USA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Results publication: PubMed 3526832Sachs 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.
- Results publication: PubMed 9385969Camirand 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.
- Results publication: PubMed 15809605Goldberg 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.
- Results publication: PubMed 850700Castanares S. Classification of baggy eyelids deformity. Plast Reconstr Surg. 1977 May;59(5):629-33. No abstract available.
- Results publication: PubMed 1852813Zarem HA, Resnick JI. Expanded applications for transconjunctival lower lid blepharoplasty. Plast Reconstr Surg. 1991 Aug;88(2):215-20; discussion 221.
- Results publication: PubMed 9507800Roberts TL 3rd. Laser blepharoplasty and laser resurfacing of the periorbital area. Clin Plast Surg. 1998 Jan;25(1):95-108.
- Results publication: PubMed 19328157Roberts 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.
- Results publication: PubMed 19931691Beylot 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.
- Results publication: PubMed 10735944Jordan 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.
- Results publication: PubMed 15216537Manstein 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.
- Results publication: PubMed 27594273Kaplan 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.
- Results publication: PubMed 25151912Gershonowitz 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for patient privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianjie Ma, Ph.D principal investigator
Department of Plastic Surgery,Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment one side BLE by NAFL and Treatment another side BLE by FMR in people with Photoaging, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Dou, bachelor (+8602984775306, 790623705@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction Scores(PSS) (time frame: 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237324, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.