Trial · NCT05386030
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. |
| Primary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders. |
| Secondary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Weeks 4, 8, 16, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 36, and 48 after last injection of initial treatment compared to the score at Baseline. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at the respective visit relative to baseline. |
| Secondary | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the independent blinded photographic reviewer´s assessment by using photographs at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. The median of all assessments for the same photograph were taken into account. |
| Secondary | Mean Change in Midface Volume Deficit | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit measured on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), and based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. |
| Secondary | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit as measured by volumetric change measurement by using 3D digital photographic images at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to Baseline. |
| Secondary | Change in Nasolabial Folds Measurements | Weeks 4, 8, 16, 24, 36, and 48 | Shift from baseline in nasolabial folds measured by the 5-point validated NLF-SRS (Nasolabial Folds Severity Rating Scale, where 0 means no NLF and 4 means Extreme Nasolabial fold) based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment. |
| Secondary | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the blinded evaluator's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The blinded evaluators assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Secondary | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the subject's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The subjects assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Secondary | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The extent of subject's satisfaction with overall treatment outcome at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the subject using the Face-Q(TM) Questionnaire "Satisfaction with Outcome". This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Definitely disagree", 2="Somewhat disagree", 3="Somewhat agree", 4="Definitely agree". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction. |
| Secondary | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The extent of subject's appearance appraisal at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the FACE-Q(TM) questionnaire "Satisfaction with Cheeks" compared to Baseline visit (i.e., change from baseline). This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Very Dissatisfied", 2="Somewhat Dissatisfied", 3="Somewhat Satisfied", 4="Very Satisfied". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction. |
| Secondary | Pain Assessment by Subjects | Baseline - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment; Week 2 - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment | Assessment of pain associated with the procedure by subjects immediately after injection and about 15, 30, 45 and 60 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine. Left and right side of the face was assessed separately. |
| Secondary | Evaluation of Injection Volume | Baseline and Week 2 | Injection volume required to achieve optimal aesthetic result at each treatment (baseline and touch-up treatment together) measured in mL. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05386030/registered