Assess Impact of Poly-L-lactic Acid on GLP1 Subjects
ConditionLaxity; Skin
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age25-65
SponsorGoldman, Butterwick, Fitzpatrick and Groff
About this trial
Clinical trial to evaluate treatments of double-dilute poly-L-lactic acid on abdominal skin laxity in GLP1 patients versus non GLP1 patients.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adult women aged 25-65 years.
Fitzpatrick skin types I-IV.
Presence of mild to moderate skin laxity of abdomen, as determined by clinical investigators.
Stable weight for 3 months, with body mass index (BMI) of 27 or less.
Disqualifiers
The presence of severe abdominal skin laxity as determined by clinical investigators.
Still actively losing weight.
Pregnancy or planned pregnancy during the study or currently breastfeeding.
Any uncontrolled systemic disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Sculptra Aesthetic
Device15 GLP1 subjects treated with Sculptra to their abdomen for skin laxity will be compared to 5 non GLP1 subjects treated with Sculptra for skin laxity.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: GLP1 PatientsActive comparator 1 intervention
Group B: NON GLP1 PatientsExperimental treatment 1 intervention
Trial outcomes
Primary 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
Month 3 and Month 9Secondary outcomes
1
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
Month 3 and Month 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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