COMPLETED

Purified Exosome Product (PEP) Injected Into the Hypodermis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical trial aims to characterize the safety, tolerability, and histological profile of PEP (Purified Exosome Product) when injected into the hypodermis of healthy adults. The main questions this study aims to answer are: Is PEP safe and tolerable when injected into the hypodermis of healthy adults? Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.

Official Title

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

Quick Facts

Study Start:2025-04-14

Study Completion:2025-12-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06429033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

John H Joseph, MD

PRINCIPAL_INVESTIGATOR

Clinical Testing Center

Study Locations (Sites)

Clinical Testing of Beverly Hills

Encino, California, 91436

United States

Collaborators and Investigators

Sponsor: Clinical Testing of Beverly Hills

John H Joseph, MD, PRINCIPAL_INVESTIGATOR, Clinical Testing Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14

Study Completion Date2025-12-18

Study Record Updates

Study Start Date2025-04-14

Study Completion Date2025-12-18

Terms related to this study

Additional Relevant MeSH Terms

Safety