Mid-face Volume Deficiency Clinical Trial
| Verified date | February 2016 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Australia: Australian Therapeutic Goods Administration (TGA) |
| Study type | Interventional |
This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | October 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician Exclusion Criteria: - Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound. - Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound. - Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study - Subjects with a history of alcoholism or drug abuse or dependence |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
Australia,
Callan P, Goodman GJ, Carlisle I, Liew S, Muzikants P, Scamp T, Halstead MB, Rogers JD. Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study. Clin Cosmet Investig Dermatol. 2013 Mar 20;6:81-9. doi: 10.2147/CCID.S40581. Print 2013. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With a = 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 4 | The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale where:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported. | Baseline, Week 4 | No |
| Primary | Percentage of Participants With a = 1 Point Improvement From Baseline in the Subject's Global Aesthetic Improvement Scale (GAIS) at Week 8 | The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported. | Baseline, Week 8 | No |
| Primary | Percentage of Participants With a = 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 4 | The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported. | Baseline, Week 4 | No |
| Primary | Percentage of Participants With a = 1 Point Improvement From Baseline in the Physician's Global Aesthetic Improvement Scale (GAIS) at Week 8 | The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants +1=improved and +2=much improved is reported. | Baseline, Week 8 | No |
| Primary | Percentage of Participants a =1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 4 | The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss. | Baseline, Week 4 | No |
| Primary | Percentage of Participants a = 1 Point Improvement From Baseline in the Physician's Mid-face Volume Deficit Scale (MFVDS) at Week 8 | The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS: 0=no facial volume loss to 5=severe volume loss. | Baseline, Week 8 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 52 | The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 52, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 52 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 78 | The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 78, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 78 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 MFVDS Scores at Week 104 | The physician determined the degree of midface volume deficiency in each participant at week 8 and Week 104, relative to before treatment using the 6-point MFVDS: 0-no facial volume loss to 5=severe volume loss. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 104 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 52 | The participant rated their midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 52 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 78 | The participant rated their midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 78 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Subject's GAIS Scores at Week 104 | The participant rated their midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 104 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 52 | The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 52 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 52 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 78 | The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 78 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 78 | No |
| Primary | Percentage of Participants Who Maintained Their Week 8 Physician's GAIS Scores at Week 104 | The physician rated the participant's midface appearance compared to before treatment at Week 8 and Week 104 using the 5-point GAIS scale:-2=much worse to +2=much improved. The percentage of participants who are able to maintain their Week 8 score is reported. | Baseline, Week 8, Week 104 | No |
| Secondary | Percentage of Participants With a = 1 Point Improvement From Baseline in the Investigator's Wrinkle Assessment Scale (WAS) | The physician assessed the left side and the right side of the participant's face for severity of nasolabial folds using the 5-point WAS where: 0=no wrinkle to 4=very deep wrinkle. | Baseline, Weeks 4, 8, 52, 78 and 104 | No |
| Secondary | Change From Baseline in the MFVDS Score | The physician determined the degree of midface volume deficiency in each participant, relative to Baseline (before treatment) using the 6-point MFVDS where: 0=no facial volume loss to 5=severe volume loss. A negative change from Baseline indicates improvement. | Baseline, Weeks 4, 8, 52, 78 and 104 | No |
| Secondary | Physician Assessment of Global Aesthetic Improvement Score (GAIS) | The physician rated the participant's midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. | Baseline, Weeks 4, 8, 52, 78 and 104 | No |
| Secondary | Subject's Assessment of Global Aesthetic Improvement Score (GAIS) | The participant rated their midface appearance compared to Baseline (before treatment) using the 5-point GAIS scale:-2=much worse to +2=much improved. | Baseline, Weeks 4, 8, 52, 78 and 104 | No |
| Secondary | Change From Baseline in the Subject's Self-Perception of Age (SPA) | The participant rated their facial age in years at Baseline and Weeks 4, 8, 52, 78 and 104. A negative change from Baseline indicates an improvement. | Baseline, Weeks 4, 8, 52, 78 and 104 | No |
| Secondary | Percentage of Participants Satisfied or Very Satisfied With the Treatment | Participants rated their satisfaction with treatment using a 5-Point Scale where: 1=very unsatisfied to 5=very satisfied. | Week 8 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06034522 -
Clinical Investigation Evaluating the Safety and Feasibility of Adipearl
|
N/A |