Facial Laxity, Fine Lines, Volume Loss, Wrinkle
Conditions
Brief 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.
Detailed 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.
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
Sponsors
Goldman, Butterwick, Fitzpatrick and Groff
Obagi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All subjects will receive up to two treatments of Obagi® Saypha® MagIQ™ Injectable HA gel to the mid-face and/or nasolabial folds.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
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 provide written informed consent form and photography release for research, publication, and/or commercial use. 6. In good general health as determined by the investigator based on medical history and clinical judgment. 7. Willing to maintain the study-specified skincare regimen and refrain from initiating new topical or procedural facial treatments during the study period. 8. For subjects of childbearing potential, a negative urine pregnancy test at screening/baseline and at all subsequent visits, as applicable. 9. 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
1. Prior use of injectable treatments to the face within the past 12 months, including HA fillers and biostimulator injectables, i.e. calcium hydroxyapatite, poly-L-lactic acid (e.g., Sculptra, Radiesse), platelet-rich plasma (PRP), platelet-rich fibrin (PRF) Any facial surgical procedure (e.g., facelift, facial implants) within the past 12 months. 2. Use of neuromodulators (e.g., botulinum toxin) to the face or neck within 6 months prior to study enrollment or at any time during the study period. 3. Use of dermal fillers of any kind during the study period. 4. Use of at-home energy-based devices intended for rejuvenation or fibroblastic/collagen stimulation within 30 days prior to treatment and during the study period. 5. Use of systemic retinoids (e.g., isotretinoin) within 3 months prior to enrollment 6. Active infection, open wounds, or inflammatory dermatoses (e.g., eczema, psoriasis, dermatitis) in the treatment area. 7. Plants to become pregnant during the study period, or current breastfeeding. 8. Known allergy or hypersensitivity to lidocaine, tetracaine, or other local anesthetics. 9. Coagulation disorders or use of anticoagulants or antiplatelet medications that cannot be safely discontinued per investigator discretion. 10. History of autoimmune connective tissue diseases (e.g., systemic lupus erythematosus, scleroderma, dermatomyositis). 11. Current or recent use (within the past 3 months) of systemic immunosuppressive medications. 12. Any uncontrolled systemic condition that may increase risk or interfere with study participation, including but not limited to poorly managed diabetes, thyroid dysfunction, or cardiovascular disease. 13. Clinically significant neurological, psychological or psychiatric conditions, or any condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results. 14. Current use of tobacco or nicotine-containing products, or use within 6 months prior to enrollment; participants must also agree to abstain from tobacco and nicotine-containing products for the duration of the study. 15. Participation in any other interventional clinical study within 30 days prior to enrollment or during the course of this study. 16. Unwillingness to refrain from undergoing any additional aesthetic treatments to the face and neck (e.g., lasers, injectables, energy-based devices, cosmeceuticals, etc.) from screening through the end of the study period. 17. Use of sunless tanner or have spray tanned in the treatment areas 4 weeks prior to study treatment. 18. History of keloids or scarring/tattoos in the treatment area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Aesthetic Improvement Scale (PGAIS) | Day 14 and Day 60 | Circle One: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (SGAIS) | Day 14 and Day 60 | Circle One: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse |
| Midface Volume Deficit Scale | Baseline, Day 14, Day 60 | Circle One: 0- None 1. Minimal 2. Mild 3. Moderate 4. Significant 5. Severe |
| Nasolabial Folds Wrinkle Severity Rating Scale | Baseline, Day 14, Day 60 | Circle One 1. Absent 2. Mild 3. Moderate 4. Severe 5. Extreme |
Countries
United States
Contacts
CONTACTAndrea Pacheco
Outcome results
None listed