Injecting Purified Exosome Product into the Skin

A Phase 1 Controlled Study to Evaluate the Safety and Tolerability of Intradermal Administered Purified Exosome Product (PEP) in Healthy Adults

This study is testing if a new skin injection made from purified exosomes is safe for healthy adults who are having body reduction surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Clinical Testing of Beverly Hills (Academic / other)
• Locations: 1 site (Encino, California)
• Trial ID: NCT06429033 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of a Purified Exosome Product (PEP) when injected into the hypodermis of healthy adults. Participants, who are scheduled for elective body reduction surgery, will receive a single dose of PEP in one area of their abdomen, while a similar area on the opposite side will serve as a control. The study is designed as a non-randomized, within-subject, controlled trial, where safety data will be collected through monitoring for adverse events and laboratory tests. The primary goal is to assess the safety profile of PEP compared to the control tissue.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 who are planning elective body reduction surgery to remove excess skin on the abdomen.

Not a fit: Patients with significant health issues or those not undergoing planned elective body reduction surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety of using PEP for enhancing skin quality and potentially improve outcomes in aesthetic procedures.

How similar studies have performed: While this approach is novel, similar studies evaluating exosome therapies have shown promising results in other contexts.

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.

Where this trial is running

Encino, California

• Clinical Testing of Beverly Hills — Encino, California, United States (Recruiting)

Study contacts

• Principal investigator: John H Joseph, MD — Clinical Testing Center
• Study coordinator: Mary Hayes

Conditions Safety