Correction of Volume Loss in the Infraorbital Hollow Area Clinical Trial
Official title:
Pilot Study to Assess the Effectiveness and Safety of Belotero Balance® Injection for Volume Augmentation of the Infraorbital Hollow
| Verified date | November 2023 |
| Source | Merz North America, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The pilot study aims to define safety, effectiveness, and patient-reported outcomes for Belotero Balance® use in the infraorbital hollows.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | March 11, 2020 |
| Est. primary completion date | June 18, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 22 Years and older |
| Eligibility | Inclusion Criteria: - Has right and left infraorbital hollow (IOH) volume deficit with a rating of 2 or 3 (moderate or severe) on the MIHAS. - Has the same MIHAS score on both IOHs (i.e., IOHs are symmetrical). - Is at least 22 years of age. Exclusion Criteria: - Ever been treated with fat injections or permanent and/or semi-permanent dermal fillers in the midfacial region. - Received lower eyelid and/or malar region treatments with any absorbable or temporary fillers such as porcine-based collagen fillers, hyaluronic acid (HA) products, RADIESSE®, poly L-lactic acid (PLLA) or received mesotherapy treatment to the area within the past 24 months or plans to receive such treatments during participation in the study. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Center for Laser and Facial Surgery, Merz Investigational Site #0010353 | Nashville | Tennessee |
| United States | Private Practice, Merz Investigational Site #0010413 | New York | New York |
| United States | Center for Sight, Merz Investigational Site #0010414 | Sarasota | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merz North America, Inc. |
United States,
Biesman B, Verma A, Cheng N, Duncan A. Development and Validation of a Photonumeric Scale for Evaluation of Infraorbital Hollowing. J Drugs Dermatol. 2023 Jan 1;22(1):74-81. doi: 10.36849/JDD.7191. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Responder Rate Compared to the Untreated Control Group According to the Merz Infraorbital Hollow Assessment Scale (MIHAS). | MIHAS was a 5 point scale ranging as: Grade 0 (none to minimal), Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved greater than or equal to (>=) 1 grade improvement on both IOHs on the MIHAS. | Baseline up to Month 2 | |
| Secondary | Change From Baseline in Rasch-Transformed Score for the Face-Q Satisfaction With Eyes | The FACE-Q is a set of standardized patient-reported outcome scales for participants undergoing facial cosmetic procedures. The participants answered 7 questions of the FACE-Q satisfaction with eyes scale using a 4 point scale where: 1 (very dissatisfied), 2 (somewhat dissatisfied), 3 (somewhat satisfied), 4 (very satisfied). The sum scores of the FACE-Q satisfaction with eyes questionnaire and the Rasch-transformed scores ranging from 0 to 100 were summarized by treatment arm. Higher scores reflected a better outcome. | Baseline and Month 2 | |
| Secondary | Global Aesthetic Improvement Scale (GAIS) Scores | 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). | Baseline up to Month 2 | |
| Secondary | GAIS Scores as Assessed by Participants | Participants evaluated their IOHs on 7 point rating scale ranging from: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), -3 (very much worse). | Baseline up to Month 2 | |
| Secondary | Responder Rate in the Treatment Group and the Untreated Control Group According to MIHAS as Assessed by Independent Panel Reviewers | MIHAS was a 5 point scale ranging as: 0 (none to minimal), 1 (mild), 2 (moderate), 3 (severe), 4 (extreme). Responder rate was defined as percentage of participants with treatment response who achieved >=1 improvement on both IOHs compared to baseline. A participant was considered a responder if a treatment response of at least a 1-point change on both IOHs was determined by independent panel reviewers. | Baseline up to Month 2 | |
| Secondary | Number of Participants Reporting One or More Device and/or Injection Related Treatment-emergent Adverse Events (TEAEs) and Device and/or Injection Related Serious TEAEs | Treatment Group: Baseline up to Month 13; Untreated Control Group: Baseline up to Month 2 |