Efficacy and Safety of Overnight Occlusive HA35 Gel for Facial Aesthetic Improvement (HA35-FACIAL)
A Prospective, Single-Arm, Open-Label Pilot Clinical Study to Evaluate Efficacy and Safety of Overnight Occlusive Topical 10% 35 kDa Hyaluronan (HA35) Gel for Facial Subcutaneous Fat Appearance, Erythema, Skin Radiance, and Pore Condition
연구 개요
상태
정황
상세 설명
This prospective, single-center, single-arm, open-label pilot clinical study investigates the efficacy and safety of overnight occlusive topical 10% high-concentration 35 kDa hyaluronan (HA35) gel for improving multiple facial aesthetic outcomes, including subcutaneous fat appearance, inflammatory erythema, skin radiance, and nasal alar pore condition.
Eligible subjects will apply HA35 gel to the entire face before sleep, covered with an occlusive film to retain moisture, and left in place overnight. The intervention will be administered once every 2 days for 5 applications over 10 days.
Outcomes will be assessed at baseline, after 1 application, and after 5 applications using a standardized 0-10 Numeric Rating Scale (NRS) for subcutaneous fat thickness, erythema severity, skin radiance, and pore enlargement. Local skin tolerability and adverse events will be monitored throughout the study.
This is a non-invasive, non-pharmacological aesthetic intervention with minimal risk. All procedures are conducted in accordance with the Declaration of Helsinki, and written informed consent is obtained from all subjects prior to enrollment.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age 18-60 years, male or female
- Seeking non-invasive improvement of facial appearance
- Presenting with at least one of: facial subcutaneous fat accumulation, facial erythema, skin dullness, nasal alar pore enlargement
- Baseline NRS score ≥2 for at least one target parameter
- Ability to complete self-assessments
- Signed written informed consent
Exclusion Criteria:
- Facial aesthetic treatments (injection, laser, fat reduction, peeling) within 2 weeks
- Active facial dermatitis, infection, or open wounds
- Known hypersensitivity to hyaluronan or gel components
- Pregnant or lactating women
- Severe systemic disease or uncontrolled medical condition
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HA35 Overnight Occlusive Topical Gel Group
Participants receive 10% high-concentration 35 kDa HA35 gel as overnight occlusive topical application to the entire face, once every 2 days for 5 applications over 10 days.
Efficacy on facial fat, erythema, radiance, pores, and safety will be evaluated.
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A topical, non-pharmacological facial gel containing 10% high-concentration 35 kDa hyaluronan fragment.
Applied under occlusive conditions overnight to improve facial subcutaneous fat appearance, reduce erythema, enhance radiance, and improve pore condition.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Facial Subcutaneous Fat Thickness NRS Score (0-10)
기간: Baseline to after 1 application and after 5 applications
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Change in facial subcutaneous fat thickness assessed by 0-10 NRS, 0 = normal, 10 = maximum thickness.
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Baseline to after 1 application and after 5 applications
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Facial Inflammatory Erythema Severity (0-10 NRS Score)
기간: Baseline (Day 0) to Day 2 and Day 10
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Change in facial inflammatory erythema severity, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no redness and 10 = maximum facial redness and inflammation.
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Baseline (Day 0) to Day 2 and Day 10
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Change in Facial Skin Radiance (0-10 NRS Score)
기간: Baseline (Day 0) to Day 2 and Day 10
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Change in perceived facial skin radiance and brightness, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = dull/lifeless skin and 10 = bright, glowing skin.
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Baseline (Day 0) to Day 2 and Day 10
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Change in Nasal Alar Pore Enlargement Severity (0-10 NRS Score)
기간: Baseline (Day 0) to Day 2 and Day 10
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Change in the severity of nasal alar pore enlargement, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 = no visible pores and 10 = maximum pore size and visibility.
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Baseline (Day 0) to Day 2 and Day 10
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Incidence and Severity of Local Skin Adverse Events
기간: Baseline (Day 0) to Day 2 and Day 10
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Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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Baseline (Day 0) to Day 2 and Day 10
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Incidence and Severity of Local Skin Adverse Events
기간: From Day 0 to Day 10
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Number and severity of treatment-related local skin adverse events (e.g., irritation, redness, allergic reaction) reported during the study.
Severity is graded using the Common Terminology Criteria for Adverse Events (CTCAE).
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From Day 0 to Day 10
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HA35202603
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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