Assess Injectable Hyaluronic Acid Gel for the Treatment of Volume Loss, Skin Laxity and Fine Lines

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-75
SponsorGoldman, Butterwick, Fitzpatrick and Groff

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult subjects aged 30 to 75 years at the time of screening/baseline.

Fitzpatrick skin types I-VI.

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.

Disqualifiers

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.

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.

Use of dermal fillers of any kind during the study period.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Obagi® Saypha® MagIQ™ Injectable Hyaluronic Acid

    Other intervention

    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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Obagi® Saypha® MagIQ™ Injectable Hyaluronic AcidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Physician Global Aesthetic Improvement Scale (PGAIS)

Circle One: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

Time frame
Day 14 and Day 60

Secondary outcomes

1

Subject Global Aesthetic Improvement Scale (SGAIS)

Circle One: 1. Very Much Improved 2. Much Improved 3. Improved 4. No Change 5. Worse

Time frame
Day 14 and Day 60
2

Midface Volume Deficit Scale

Circle One: 0- None 1. Minimal 2. Mild 3. Moderate 4. Significant 5. Severe

Time frame
Baseline, Day 14, Day 60
3

Nasolabial Folds Wrinkle Severity Rating Scale

Circle One 1. Absent 2. Mild 3. Moderate 4. Severe 5. Extreme

Time frame
Baseline, Day 14, Day 60

Other outcomes

Sponsors and contacts

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