Assess Impact of Microdroplet Hyaluronic Acid Filler on Skin Quality in Patients on Glucagon-like Peptide-1 Agonists

ConditionWrinkle
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age25-50
SponsorGoldman, Butterwick, Fitzpatrick and Groff

About this trial

Clinical trial to assess the effect of microdroplet hyaluronic acid filler to the cheek skin (SKINVIVE™, JUVÉDERM®, Irvine, CA) on skin quality in patients undergoing medical weight loss with GLP-1 therapy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult women aged 25-50 years.

Fitzpatrick skin types I-VI.

Current treatment with a stable dose of GLP-1 agonist medication for at least the last 6 months, for 16 of the enrolled subjects. Remaining 8 subjects should not be taking or have a history of taking a GLP-1 agonist therapy in the last year.

Presence of moderate skin changes (as defined by Modified Griffiths' Scale, with an average score of 4-6) in the following criteria: skin radiance/brightness, skin elasticity, tone evenness, skin firmness, fine lines, global wrinkles, and skin smoothness (tactile and visual).

Disqualifiers

The presence of severe facial skin aging (as defined by Modified Griffiths' Scale, with an average score of 7-9) or minimal facial skin aging (as defined by Modified Griffiths' Scale, with an average score of 0-3).

Females who are pregnant, planning a pregnancy, or currently breast feeding during the study.

Any uncontrolled systemic disease.

History of autoimmune connective tissue disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Skinvive

    Device

    16 GLP1 subjects treated with Skinvive to their cheeks for skin quality will be compared to 8 NON-GLP1 subjects treated with Skinvive for skin quality.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: GLP1 PatientsActive comparator 1 intervention
Group B: NON GLP1 PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Global Fine Lines

Score 0 no fine lines thru 9 numerous, many fine lines

Time frame
Screening, Day 30, Day 60
2

Overall Hyperpigmentation

Score 0= no hyperpigmentation thru 9= significant hyperpigmentation

Time frame
Screening, Day 30, Day 60
3

Skin Tone Evenness

Score 0= Very even tone thru Score 9= Uneven, discolored appearance (brown and/or red colors)

Time frame
Screening, Day 30, Day 60
4

Skin Firmness

Score 0= Firm, tight feeling skin thru Score 9= Loose, lax feeling skin

Time frame
Screening, Day 30, Day 60

Secondary outcomes

1

Physical Global Aesthetic Improvement Scale

Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2

Time frame
Day 30 and Day 60
2

Subject Global Aesthetic Improvement Scale

Assess improvement of Abdominal skin laxity: Much Improved 2 Improved 1 No Change 0 Worse -1 Much Worse -2

Time frame
Day 30 and Day 60

Other outcomes

Sponsors and contacts

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