NCT Number: NCT04577898
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.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
United States, California, Encino, California, United States
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.
Subjects will receive their initial treatment with RHA® Redensity Eye at Visit 1b.
Subjects will follow the same schedule as those initially randomly assigned to the RHA® Redensity Eye group: RHA® Redensity Eye will be administered on the same day (Visit 1b). Subjects will come to the site 12 weeks after their initial treatment. Afterwards, subjects will proceed to Phase 2.
Phase 2 and Exit visit:
Phase 2 will occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group (after Phase 1b).
All these subjects will come to the site 24 weeks, and 52 weeks after their initial treatment. All subjects will be followed for 52 weeks after their initial treatment with RHA® Redensity Eye.
Subjects will be offered retreatment (52 weeks after their initial treatment). Retreatment will be administered if the TI deems it to be appropriate and the subject agrees. If the subject does not receive retreatment, Visit at 52 weeks after initial treatment will become the Exit visit.
If the subject receives retreatment, the subjects will come to the site 12 weeks after retreatment for follow-up and safety assessments. This will be the Exit visit.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
Time frame: 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.
Time frame: 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.
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
The GAI will be assessed using the pre-injection baseline photograph. Phase 3 - Phase 2: Subjects from No-Treatment group receive their treatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Time frame: Period 3 - Phase 2 - ITT population - Weeks 12, 24, 52 after last treatment and at Week 12 after retreatment.
The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
The GAI will be assessed using the pre-injection baseline photograph. Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Time frame: Period 3: Phase 2 - ITT population - Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
The TIOHS is a validated 5-point scale for assessing Infra-orbital hollows severity. Possible scores range from 0 (Absent) to 4 (Very Severe).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Time frame: Period 3: Phase 2 - ITT population - Change from Baseline at Weeks 12, 24, 52 after initial treatment and at Week 12 after retreatment.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 7 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 7 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).
Period 3 - Phase 2: Subjects from No-Treatment group receive their teatment with RHA® Redensity Eye following primary endpoint assessment, and enter into Phase 2. Phase 2 occur 12 weeks after receiving initial treatment with RHA® Redensity Eye for subjects in the RHA® Redensity Eye group and the No-treatment control group, data are pooled for analysis.
Teoxane SA
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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