Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07332650
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 55 years;
* Body Mass Index (BMI) between 18.5 and 24.95 kg/m².
* Skin laxity of the gluteal region defined as sagging and reduced tightness of the skin.
* Women of childbearing potential must be willing to abide by the contraceptive requirements
* Ability to understand the study and provide informed consent, attend follow-up visits, and follow post-injection instructions.
Exclusion Criteria:
* Pregnancy or breastfeeding, or planned pregnancy/lack of adequate contraception (through 8 weeks post-study);
* Is planning to donate/bank or retrieve eggs (ova, oocytes) or donate sperm during the study or within 8-weeks of the end of participation of the clinical investigation.
* Active infection, inflammation or lesions at or near the treatment site.
* Acute infection at screening;
* History of autoimmune disease;
* Immune deficiencies;
* History of hypertrophic scarring or keloid formation;
* Previous surgical procedures involving the buttocks
* Aesthetic procedure on the buttocks (including fillers, elevation wires, radiofrequency, ultrasound, cryotherapy, fat injection, neurotoxin, laser or light treatment, or chemical peel) within 6 months prior to randomization.
* Hemorrhagic disease or ongoing use of antiplatelets/anticoagulant therapy.
* Treatment with chemotherapy, immunosuppressive agents, systemic corticosteroids within 3 months before treatment (inhaled or ophthalmic corticosteroids are allowed).
* Use of hormonal replacement therapy (HRT) unless the participant has been on a stable dose for at least 3 months prior to screening and does not plan to make any changes to the HRT regimen during the study period.
* Use of topical corticosteroids, topical prescription retinoids in the treatment area within 1 month of the Baseline visit or systemic retinoid treatment within 6 months of the baseline visit, or plan to receive such treatment.
* Use of other agents that inhibit collagen production.
* Known allergy or hypersensitivity to any component of the investigational product.
* History of herpes simplex rashes, malignant skin diseases, or any other serious dermatologic or systemic disease.
* Presence of any condition that may impair wound healing (e.g., connective tissue disorders, severe malnutrition).
* Planned or ongoing cosmetic procedures involving the buttocks or surrounding area during the period of clinical investigation.
* Extensive tattoos covering \>50% of the total gluteal area.
* Participants actively taking GLP-1 medications with the intention of achieving additional weight loss (expected \>10% during study) will be excluded. Participants on a stable GLP-1 regimen (≥3 months) for diabetes management or weight maintenance, with documented weight stability (±10% in past 6 months) and no planned or expected weight change \>10%, may be included.
* Any other medical or psychological condition that, in the opinion of the investigator, may interfere with participation in clinical research or evaluation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07332650
Study Brief:
Protocol Section:
NCT07332650