Safety of Topical Exosome-Containing Liquid in Healthy Volunteers for Future Surgical Wound Use

Korábbi kezelés

• History of severe allergy, anaphylaxis, or hypersensitivity to topical liquids, dressings, biological products, exosome-containing products, or any component of the investigational product or vehicle liquid.
• Use of systemic corticosteroids, immunomodulatory drugs, biological agents, or investigational products within 30 days before enrollment.
• Use of topical corticosteroids, topical immunomodulators, topical antibiotics, retinoids, keratolytic agents, or other medicated topical products on or near the planned application sites within 14 days before enrollment.
• Participation in another interventional clinical trial within 30 days before enrollment.

Más betegség

• Any active skin disease, dermatitis, eczema, psoriasis, urticaria, acneiform eruption, skin infection, open wound, scar, tattoo, burn scar, pigmentation disorder, or clinically significant skin abnormality at the planned application sites.
• Current acute illness, fever, or active infection.
• Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
• Clinically significant hepatic, renal, cardiovascular, hematologic, endocrine, neurologic, psychiatric, or systemic disease that may increase risk or interfere with interpretation of study results.
• Known active malignancy or history of malignancy within the past 5 years.
• Positive screening test for clinically relevant transmissible infection, if required by the protocol.
• Any condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study results.

Laborértékek

• Blood donation or major blood loss within 30 days before enrollment, if laboratory safety monitoring is included in the protocol.

Egyéb

• Pregnancy or breastfeeding.
• Positive pregnancy test at screening or before first application in women of childbearing potential.

• Healthy adult volunteers aged 18 to 55 years.
• Able and willing to provide written informed consent.
• No clinically significant abnormality based on medical history, physical examination, vital signs, and screening laboratory tests.
• Intact healthy skin at the planned application sites.
• Willingness to avoid applying other topical products, cosmetics, antiseptics, or irritant substances to the application sites during the study period.
• Willingness to avoid excessive sun exposure, sauna, swimming pool use, and mechanical irritation of the application sites during the study period.
• Willingness to comply with all study visits, topical application procedures, local skin assessments, skin photography, safety assessments, and follow-up.
• For women of childbearing potential, a negative pregnancy test before first application and willingness to use an acceptable method of contraception during the study period.