A Randomized, Blinded Evaluator, No-treatment Control, Multicenter, Prospective Clinical Study of RHA® Redensity Eye for the Treatment of Moderate to Severe Tissue Volume Deficiencies in the Infraorbital Regions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Teoxane SA
- 入组人数
- 248
- 试验地点
- 4
- 主要终点
- Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a
研究概览
简要总结
This is a multicenter, blinded evaluator, randomized, prospective, no treatment control clinical study to identify whether RHA® Redensity Eye (*) is superior to no treatment for the correction of moderate to severe tissue volume deficiencies in the infraorbital regions.
The study will include at least 20% of subjects with Fitzpatrick skin types IV-VI.
The Treating Investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate the subject's infraorbital hollows independently of each other using the Teoxane Infraorbital Hollows Scale (TIOHS) at Screening (Visit 1) for eligibility.
If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint.
Enrolled subjects will be randomly assigned in a ratio of 3:1 at Screening (Visit 1) to receive RHA® Redensity Eye or to receive no treatment (No-treatment control group).
Subjects receiving RHA® Redensity Eye will be further divided by the method of administration (i.e. injection with a 30G ½" needle or 25G 1 ½" cannula), which will be defined for each site at the beginning of the study. Site selection will aim to achieve approximately 1:1 distribution between the administration method subgroups. The BLE will be blinded to the study groups (RHA® Redensity Eye group or No treatment control group).
For subjects randomly assigned to RHA® Redensity Eye group, the study will be conducted in 2 Phases - Phase 1a and Phase 2.
For subjects randomly assigned to No-treatment control group, the study will be conducted in 3 Phases - Phase 1a, Phase 1b and Phase 2.
The Phase 1b is not applicable for the subject assigned to the RHA® Redensity Eye group.
(*): TEO-RHA-1902 was conducted with RHA® Redensity Eye Lido, that contains Lidocaine.
详细描述
Phase 1a:
Subjects who will be randomly assigned to the RHA® Redensity Eye group at Screening will receive their injection at Visit 1. Subjects will come to the site 12 weeks (primary endpoint) after the initial treatment. Afterwards, subjects will proceed directly to Phase 2.
Subjects randomly assigned to the No-treatment control group at Screening will receive no treatment in Phase 1a of the study. They will come to the site 12 weeks (primary endpoint) after randomization. After completing all assessments, subjects will immediately begin Phase 1b (Visit 1b is on the same day as Visit at Week 12) and will receive their initial treatment with RHA® Redensity Eye.
Phase 1b:
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group. Once all evaluations applicable for Visit at Week 12 are completed, subjects will proceed directly to Visit 1b (on the same day). Evaluations completed at Week 12 will be used for Visit 1b and will become the new Baseline for Phase 1b.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient, male or female of any race, 22 years of age or older
- •Infra-orbital Hollows of grade 2 to 3 on the TIOHS (ranging from 0 to 4) who is seeking treatment of moderate to severe tissue volume deficiencies in the infra-orbital region (realistic and achievable as per TI opinion). Bilateral symmetry is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the subject is eligible, the BLE's assessment will be used for the Baseline for the primary endpoint. If the TI and the BLE do not agree on eligibility, or if their assessments differ by 2 points or more on the scale, the subject will not be eligible.
- •Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- •Able to follow study instructions and complete all required visits.
- •Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
排除标准
- •Female subjects that are pregnant, breast-feeding or of childbearing potential and not practicing reliable birth control
- •Known hypersensitivity/allergy to any component of the study devices
- •Clinically significant active skin disease within 6 months
- •Has a history of or currently has an auto-immune disease.
研究组 & 干预措施
RHA® Redensity Eye Group
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
干预措施: RHA® Redensity Eye (Device)
No-Treatment Control First, Then RHA Redensity Eye Treatment Group
During Phase 1a, participants from No-treatment control group do not receive treatment. Primary endpoint assessments are done at Week 12. Once all evaluations applicable for Primary Endpoint at Week 12 are completed, subjects proceed directly to Phase 1b (on the same day).
Phase 1b is only applicable to subjects initially randomly assigned to the No-treatment control group.
Phase 1b: Subjects receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye is administered on the same day (Visit 1b). Subjects come to the site 12 weeks after their initial treatment.
RHA® Redensity Eye is injected from the sub-dermis to the periosteum in the infraorbital hollow.
Up to 1.0 mL per eye at each treatment (max: 2.0 mL per treatment). No touch-up treatment provided.
结局指标
主要结局
Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Week 12 After Last Treatment, Using the TIOHS - Phase 1a
时间窗: Period 1 - Phase 1a: Week 12 after last treatment
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe). Change = (Week 12 - Baseline score). A TIOHS change of 1-grade will be considered clinically significant. Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
The Modified FACE-Q "Appearance of Lower Eyelids" Change From Baseline Score for Subjects Treated With RHA® Redensity at Week 12 After Last Treatment - Phase 1a
时间窗: Period 1 - Phase 1a: Change from Baseline at Week 12 after last treatment
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective. The modified FACE-Q questionnaire is composed of 4 questions with a score linked to answers (1 being "Not at all" and 4 being "Extremely"). To calculate the FACE-Q score, outcomes from all 4 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100). Phase 1a: Subjects are randomly assigned to the RHA® Redensity Eye group or to the to the No-treatment control group, and come to the site 12 weeks (primary endpoint) after randomization.
次要结局
- Number of Subjects Who Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Subject at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2(Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.)
- Number of Subjects Scored Themselves Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Last Treatment and at Week 12 After Retreatment - Phase 2(Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.)
- Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2(Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.)
- Change of 1 Point From Baseline in Infra-Orbital Hollows Severity Rated by the Blinded Live Evaluator (BLE) at Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment Using the TIOHS - Phase 2(Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.)
- Subject's Perception of Treatment Effectiveness as Per the "Appearance of Lower Eyelids " FACE-Q Scale Questionnaire at Baseline, Weeks 12, 24, 52 After Initial Treatment and at Week 12 After Retreatment - Phase 2(Period 3: Phase 2 - ITT population - Change from Baseline at Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.)