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| Name | Class |
|---|---|
| Obagi | UNKNOWN |
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Clinical trial to assess the real-world effectiveness of Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid (HA) gel for the treatment of mild-to-moderate facial aging, including volume loss, fine lines, and skin laxity, following treatment administered using routine clinical injection techniques over the course of 60 days.
100 patients total who demonstrate mild-to-moderate signs of facial aging, including volume loss, fine lines, and skin laxity will receive up to two treatments with Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid gel. Patients will return for follow up visits at day 14 and day 60 where they will undergo standardized 2D photography, VISIA photography and assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid | Experimental | Enrolled subjects will receive Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid | Other | Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid is a sterile, biodegradable, homogenized and isotonic HA gel that uses an innovative crosslinking technology (MACRO Core Technology) to achieve a stable 3D HA matrix |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Aesthetic Improvement Scale (PGAIS) | Circle One:
| Day 14 and Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (SGAIS) | Circle One:
| Day 14 and Day 60 |
| Midface Volume Deficit Scale | Circle One: 0- None
|
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Inclusion Criteria:
Adult subjects aged 30 to 75 years at the time of screening/baseline.
Fitzpatrick skin types I-VI.
Investigator classification of the subject as having mild-to-moderate facial aging in at least one (≥1) facial areas, defined as meeting the following scale criteria at screening/baseline:
Midface Volume Deficit Scale (Appendix A): score of 2-3 Nasolabial Folds Severity Scale (Appendix B): score of 2 or 3
Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments.
Willing and able to provide written informed consent form and photography release for research, publication, and/or commercial use.
In good general health as determined by the investigator based on medical history and clinical judgment.
Willing to maintain the study-specified skincare regimen and refrain from initiating new topical or procedural facial treatments during the study period.
For subjects of childbearing potential, a negative urine pregnancy test at screening/baseline and at all subsequent visits, as applicable.
Female subjects of childbearing potential must agree to use an acceptable method of contraception throughout the study and must have been using systemic contraception consistently for at least 30 days prior to enrollment, unless they meet criteria for non-childbearing potential.
Subjects are considered not of childbearing potential if they meet one of the following:
History of hysterectomy or bilateral oophorectomy, or No menses for at least 12 consecutive months without an alternative medical cause.
Or, if of childbearing potential, must agree to use an effective form of contraception during the course of the study. Acceptable methods include:
Oral contraceptive pill, injection, implant, patch, vaginal ring, or intrauterine device (IUD) Intrauterine coil Bilateral tubal ligation Hysterectomy Barrier method used with an additional form of contraception (e.g., spermicide, sponge, or condom) Abstinence (must agree to use a barrier method if sexual activity begins during the study) Partner with a vasectomy (if not, subject must agree to use a barrier methods
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 8586571004 | apacheco@clderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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All subjects will receive up to two treatments of Obagi® Saypha® MagIQ™ Injectable HA gel to the mid-face and/or nasolabial folds.
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| Baseline, Day 14, Day 60 |
| Nasolabial Folds Wrinkle Severity Rating Scale | Circle One
| Baseline, Day 14, Day 60 |