A Prospective, Phase 4, Multicenter, Open-label Pilot Study of Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid Gel for the Treatment of Volume Loss, Skin Laxity and Fine Lines
Goldman, Butterwick, Fitzpatrick and Groff
Summary
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.
Description
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.
Eligibility
- Age range
- 30–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Adult subjects aged 30 to 75 years at the time of screening/baseline. 2. Fitzpatrick skin types I-VI. 3. 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 4. Willing and able to comply with all study requirements, including scheduled visits, treatment protocol, and follow-up assessments. 5. Willing and able to pro…
Interventions
- OtherObagi® Saypha® MagIQ™ Injectable Hyaluronic Acid
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
Location
- West Dermatology Research CenterSan Diego, California