Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT06429033
Brief Summary:
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.
Detailed Description:
This is a prospective, non-randomized, within-subject, controlled, single center, open-label study. Up to 9 healthy adult participants with planned elective body reduction surgery to remove excess skin on the abdomen in 30-45 days will be enrolled and injected with a single dose of PEP Drug Product reconstituted in Lactated Ringers (USP) solution in a defined area of the abdominal hypodermis. Similar tissue from the participant's contralateral side of the abdomen will serve as the control. Excised tissue will be harvested and analyzed for key biological markers for skin quality and senescence such as collagen and elastin. The primary goal of this investigator-initiated study is to determine safety of subcutaneous PEP Drug Product when reconstituted in Lactated Ringers solution. Safety data will be collected with frequent monitoring for adverse events, laboratory testing, vital signs, and ECGs.
Note: The decision to undergo abdominoplasty will be made outside of this study and data/safety in the plastic surgery procedure for abdominoplasty, other than informed consent, will not be a collected as a part of this study.
Study:
NCT06429033
Study Brief:
Protocol Section:
NCT06429033