Purified Exosome Product (PEP) Injected Into the Hypodermis

Launched by CLINICAL TESTING OF BEVERLY HILLS · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Purified Exosome Product (PEP) to see if it is safe and well-tolerated when injected into the skin of healthy adults. The researchers want to find out if PEP can be safely used before people have surgery to remove excess skin from their abdomen. Participants in the study will help the researchers by comparing PEP with a control treatment, meaning they'll be their own comparison group.

To be eligible for this trial, participants should be healthy adults between the ages of 18 and 65 who are planning to have elective surgery for skin removal within 12 to 18 weeks. They must also be able to agree to participate and follow the study's guidelines, such as avoiding other skin treatments during the study. Participants can expect to attend follow-up visits and be monitored closely for any reactions to the treatment. It's important to know that there are specific health conditions and recent medical histories that could disqualify someone from participating, so potential volunteers will need to discuss their health with the study team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult participants aged 18-65 (inclusive)
• • Capacity to sign informed consent.
• • Planned elective body reduction surgery to remove excess skin on the abdomen in ≥ 12 to ≤ 18 weeks
• • Participant is judged, by the clinical investigator, to be healthy as evidenced by lack of clinically significant abnormal findings on medical history, physical examination, vital signs, and clinical laboratory tests.
• • Participant should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods (laser devices, topical prescriptions, or other known hair growth treatments) in the treatment area during the entire study period.
• • Females of childbearing potential must be using an approved method of birth control for the past month and during the entire study period. Participants who can become pregnant will undergo a pregnancy test prior to treatment.
• Exclusion Criteria:
• • Participants with clinically abnormal hematology, serum chemistries, or screening laboratory results as reviewed by the clinical investigator.
• • Known history of MRSA (methicillin-resistant staphylococcus aureus).
• • Known history of COVID-19 infection in past 6 months.
• • COVID vaccine or booster dose within past 12 weeks.
• • Participants who are positive for hepatitis B surface antigen (HbsAg), hepatitis C antibody, or HIV.
• • History of antibiotic use in past 12 weeks.
• • Major surgery in past 3 months.
• • If taking hormone replacement therapy or hormones for birth control, dose must be stable for at least 6 months prior to study entry.
• • Current or regular use of corticosteroids during the previous 4 weeks, excluding inhaled or topical steroids outside of the planned treatment area.
• • Known sensitivity/allergy to study product ingredients.
• • Pregnancy and nursing or lactating.
• • Sexually active women of childbearing potential who are unwilling to use approved contraception method for three months after receiving dose of investigational drug.
• • Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
• • Clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurological, psychiatric, immunological, gastrointestinal, hematological, history of any malignancies or metabolic disease that is, in the opinion of the investigator, not stabilized or may otherwise impact the results of the study.
• • Participants with hepatic impairment
• • Participants with poorly controlled diabetes mellitus (HbA1C ≥ 8%).
• • Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• • History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• • Any surgery or treatment such as laser or chemicals in the treatment area within 6 months prior to treatment
• • History of excessive UV exposure (e.g., frequent sunburn, use of tanning beds, or prolonged outdoor activities without adequate sun protection)
• • Any medical condition that in the opinion of the investigator, such condition would compromise the safety of the participant or quality of the study data.
• • Current, or past participation in a clinical trial within the past 30 days.