BridgeMD
New treatment option for Volume Loss (Soft Tissue Ptosis or Atrophy )
Official title Restoring Facial Volume After GLP-1 Weight Loss With Radiesse
ClinicalTrials.gov ID: NCT07419854
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the potential of Calcium Hydroxylapatite (CaHA) to restore facial volume and improve skin quality in patients with GLP-1 receptor agonist-associated facial volume loss. Participants will: Schedule first dose of a prescribed GLP-1 receptor agonist drug to coincide with the baseline visit of this study Be randomly assigned to one of two groups (Group A will receive off-label injections of hyperdiluted CaHA at Month 0.
- Phase 4: studies an already-approved treatment
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Adults aged 21-65 who are initiating GLP-1 therapy (semaglutide, tirzepatide, or similar) for weight loss or diabetes-related weight management with...
- Participants must have a body mass index (BMI) meeting indications for GLP-1 therapy and within the range of 24-32
- Participants should be at the start of GLP-1 therapy (baseline visit scheduled at or within 1-2 weeks of first GLP-1 injection) so that baseline...
- Participants must have noticeable facial subcutaneous fat (no pre-existing extreme lipoatrophy) and be willing to receive facial filler injections
- Participants should be able to comply with all study visits and procedures up to 12 months
You likely can't join if
- Participants with any prior facial cosmetic procedures that could confound results e.g. facial filler or fat transfer in the past 2 years; thread...
- Participants currently using a retinoid
- Participants with active dermatologic conditions affecting the face (e.g. severe acne, psoriasis on face) or scars that would interfere with volume...
- Participants with known allergies or hypersensitivity to CaHA or lidocaine (lidocaine allergy)
- Those with a history of severe anaphylactic reactions requiring epinephrine (due to risk with injectables)
- Those with uncontrolled diabetes or major comorbid conditions that would make participation unsafe (e.g. bleeding disorders that contraindicate...
See the full eligibility criteria
- Adults aged 21-65 who are initiating GLP-1 therapy (semaglutide, tirzepatide, or similar) for weight loss or diabetes-related weight management with targeted weight loss of 20 pounds or more
- Participants must have a body mass index (BMI) meeting indications for GLP-1 therapy and within the range of 24-32
- Participants should be at the start of GLP-1 therapy (baseline visit scheduled at or within 1-2 weeks of first GLP-1 injection) so that baseline facial measurements represent their pre-weight-loss state
- Participants must have noticeable facial subcutaneous fat (no pre-existing extreme lipoatrophy) and be willing to receive facial filler injections
- Participants should be able to comply with all study visits and procedures up to 12 months
- Participants must provide written informed consent, including consent for facial imaging
- Participants with any prior facial cosmetic procedures that could confound results e.g. facial filler or fat transfer in the past 2 years; thread lifts or energy based device facial treatments in the last 1 year...
- Participants currently using a retinoid
- Participants with active dermatologic conditions affecting the face (e.g. severe acne, psoriasis on face) or scars that would interfere with volume assessment
- Participants with known allergies or hypersensitivity to CaHA or lidocaine (lidocaine allergy)
- Those with a history of severe anaphylactic reactions requiring epinephrine (due to risk with injectables)
- Those with uncontrolled diabetes or major comorbid conditions that would make participation unsafe (e.g. bleeding disorders that contraindicate injections, immunosuppression that raises infection risk, uncontrolled...
- Pregnant or breastfeeding women are excluded (GLP-1 therapies are contraindicated in pregnancy, and elective filler is avoided in pregnancy)
- Women of childbearing potential must agree to use an effective contraceptive method during the study (though pregnancy during the short study window is unlikely, this is a precaution)
- If a Participant becomes pregnant or initiates any new facial cosmetic treatment during the Study, they will be withdrawn
- Participants planning bariatric surgery or other significant weight loss interventions (besides the GLP-1 medication) in the study period
The study team makes the final eligibility decision.
Where it's taking place
- Pasadena, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pasadena, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.