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Safety and Efficacy of a 2,910 nm Fractional Ablative Fiber Laser (UltraClear®) for Improvements of Skin Laxity and Lifting of the Lower Face, Submental, and Neck Treatment Areas (UC 29-2026)

2026년 8월 9일 업데이트: FA Corporation
This study evaluates the safety and effectiveness of the UltraClear® 2,910 nm fractional ablative fiber laser for improving skin laxity and tissue lifting in the lower face, submental, and neck areas. Up to 50 adults ages 35-65 will receive two laser treatments approximately 7 weeks apart at two clinical sites. Outcomes will be assessed approximately 90 days after the second treatment using photographic analysis and investigator- and participant-reported improvement scales.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Kentucky
      • Prospect, Kentucky, 미국, 40059
        • Julene B Samuels MD, FACS
        • 연락하다:
        • 수석 연구원:
          • Julene B Samuels, MD, FACS
    • Texas
      • Houston, Texas, 미국, 77004
        • Dermatology & Laser Surgery Center
        • 연락하다:
        • 수석 연구원:
          • Paul M Friedman, MD
        • 부수사관:
          • Emily Guo, MD
        • 부수사관:
          • Christina Lopez, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  1. Fitzpatrick skin types I-III participants with Fitzpatrick Skin Types IV-VI may be enrolled only at the investigator's discretion, based on individualized risk assessment documenting skin tone-related risk of post-inflammatory hyperpigmentation, wound healing history, and prior response to ablative or energy-based treatments. Risk assessment documentation must be retained in the participant's study file. Male or female.
  2. Participants must be between 35 and 65 years of age.
  3. Participants must have the ability to receive two lower face and full neck resurfacing laser treatments with desire for improvement in lifting and skin laxity.
  4. Participants must read, understand, and sign the Informed Consent Form.
  5. Participants must be willing and able to comply with all follow-up visit requirements.
  6. Participants must agree to refrain from using cosmeceutical agents or topical agents during the study, except as directed by study investigator.
  7. Participants must be rated as (2) Moderate Sagging to (4) Very Severe Sagging based on the Merz Jawline Grading Scale (MJGS)[11].
  8. Participants must be rated as a (C) Grade 3: moderate laxity, (D) Grade 4: moderate to severe laxity or (E) Grade 5: severe laxity of the tissues of the neck based on the 5-Grade IBSA Neck Laxity Scale [12]
  9. Participants of childbearing potential must have been on an acceptable form of contraception for 30 days prior to enrollment and agree to continue using throughout the course of the study.
  10. Participants agree to maintain stable body weight, defined as no planned weight-loss program and no significant change in body weight (±10 lbs or ±5%) within 3 months prior to enrollment and throughout study participation.
  11. Participants identified as an appropriate candidate for study treatment based on principal investigator's opinion.

Exclusion Criteria:

  1. Participants must not have active localized or systemic infections.
  2. Participants must not have a compromised ability for wound healing, such as: malnutrition, steroid use, history of collagen vascular disease (e.g., lupus, scleroderma, history of keloid scar formation), atopic dermatitis or immunologic abnormalities such as vitiligo.
  3. Participants must not be current smoker or have history of regular tobacco or nicotine use within 12 months prior to enrollment.
  4. Participants must not have had treatments with systemic steroids or systemic retinoids in the 4-months prior to enrollment.
  5. Participants must not have had treatments with 5FU, diclofenac, imiquimod or PDT within 1-month prior to enrollment.
  6. Participants must not have severe or cystic facial acne; currently taking Accutane or have taken Accutane within the last 1-month.
  7. Participants must not have a known allergy to lidocaine or epinephrine, topical or injectable products containing lidocaine or any numbing medications.
  8. Participants must not have had previous surgery and/or fat transfer in the treatment area within the last 6-months.
  9. Participant must not have had injectable soft tissue fillers within the last 12-months in the treatment area.
  10. Participant must not have had Poly-L-Lactic acid (PLLA) or Calcium Hydroxylapatite (CaHA) fillers within the last 2 years in the treatment area.
  11. Participant must not have had permanent filler i.e., Polymethylmethacrylate (PMMA) in the treatment area.
  12. Participants must not have had neurotoxins within the last 4-months in the treatment area.
  13. Participant must not have a personal history of any facial threads i.e., PDO (Polydioxanone), PLLA (Polylactic acid), PCL (Polycaprolactone) in the treatment area within the last 12-months.
  14. Participant must not have had a pulse dye or vascular laser, non-ablative laser, microneedling or RF microneedling treatments in the treatment area within the last 3-months.
  15. Participant must not have had an ultrasound treatment such as HIFU, monopolar RF energy-based devices, ablative laser treatments in the treatment area within the last 6-months.
  16. Participants must not have a personal history of malignant melanoma, keloid scars, generalized psoriasis or systemic diseases that would preclude the use of topical anesthesia.
  17. Participant must not have active sunburn or excessively tanned skin.
  18. Participants must not be pregnant or planning to become pregnant, have given birth less than 3-months ago, and/or breastfeeding during the study. Participants of childbearing potential will be asked to confirm they are not pregnant at screening, at each treatment visit and at Visit 6: Day 139 ± 7 days (3-month follow-up) representing approximately 90 days following the second treatment and Visit 7: Day 229 ± 7 days (6-month follow-up).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 2910 nm fiber laser treatment
Participants receive two treatments with the UltraClear® 2,910 nm fractional ablative fiber laser to the lower face, submental region, and neck, spaced approximately 7 weeks (±7 days) apart.
장치: 2910 nm fiber laser (UltraClear®)
UltraClear® is a 2,910 nm fractional ablative erbium-doped fluoride glass fiber laser (Acclaro), FDA 510(k) cleared (K210847, K233803) for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. In this study, it is applied to the lower face, submental region, and neck using fractional ablative resurfacing, laser-coring, and full ablative resurfacing configurations, with mode and parameters selected by the investigator based on baseline anatomy and tissue laxity.
다른 이름들:
  • 2910 nm erbium doped fluoride fiber glass laser
  • 2910 nm fractional ablative laser
  • 2910 nm fiber laser

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Quantitative 2D Photographic Analysis:
기간: Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants achieving a ≥20 mm² reduction in submental area post treatment, measured by a blinded independent analyst using a five-point landmark methodology applied to standardized 2D photographs. The study-level responder rate must achieve statistical significance (p < 0.05).
Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Blinded Photographic Review
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Proportion of participants for whom ≥2 of 3 Blinded Independent Photographic Reviewers (BIPRs) correctly identify post-treatment improvement from paired baseline and Visit 6 photographs of the submental and neck regions. Pre-specified responder threshold: ≥80% of evaluable participants.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)

2차 결과 측정

결과 측정
측정값 설명
기간
Investigator Global Aesthetic Improvement Scale (iGAIS)
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Investigator Merz Jawline Grading Scale (MJGS)
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Range: 0-4 Directionality: lower score equates to better outcome (less sagging) (0= No sagging, 1= Mild sagging, 2= Moderate sagging, 3= Severe sagging, 4= Very severe sagging). Change from baseline will be assessed.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment).
Participant Global Aesthetic Improvement Scale (sGAIS)
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Range: 0-4 Directionality: higher score equates to better outcome (0= Worse, 1= No change, 2= Improved, 3= Much improved, 4= Very much improved). Proportion with any improvement from baseline.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
FACE-Q™ Satisfaction with Lower Face and Jawline (Rasch-transformed score)
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Range: 1-4, Directionality: higher score equates to increased satisfaction (1= Very dissatisfied, 2= Somewhat dissatisfied, 3= Somewhat satisfied, 4= Very satisfied). Change from baseline will be assessed.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Participant satisfaction questionnaire
기간: Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)
Range: 1-4 Directionality: higher score equates to increased satisfaction (1= very dissatisfied, 2= Dissatisfied, 3= Satisfied, 4= Very satisfied). Satisfaction questionnaire completed by participant following two 2910 nm fiber laser treatments.
Assessed at Visit 6 (Day 139 ± 7; approximately 90 days following the second treatment)

기타 결과 측정

결과 측정
측정값 설명
기간
Incidence of Treatment Emergent Adverse Events and Discomfort Scores (Safety and Tolerability)
기간: Through the study, an average of 1 year

Participant-rated discomfort via visual analog scale (VAS) will be completed following each 2910 nm fiber laser treatment. Range: 0-10 Directionality: lower score equates to less discomfort (ie. 0= No pain, 5= Moderate Pain, 10 = Worst Pain).

Evaluations of Post Treatment Responses & Adverse Events to be completed by Investigator immediately post-treatment and at at each follow-up visit. Additionally device- and procedure-related adverse as well as unrelated event monitoring to be completed throughout the study.
Through the study, an average of 1 year

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

FA Corporation

수사관

  • 수석 연구원: Paul M Friedman, MD, Dermatology & Laser Surgery Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 7일

기본 완료 (추정된)

2027년 8월 31일

연구 완료 (추정된)

2027년 8월 31일

연구 등록 날짜

최초 제출

2026년 8월 4일

QC 기준을 충족하는 최초 제출

2026년 8월 9일

처음 게시됨 (실제)

2026년 8월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 9일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UC 29-2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다