Safety of Topical Exosome-Containing Liquid in Healthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorWest Kazakhstan Marat Ospanov Medical University
About this trial
This Phase 1 split-site pilot study will evaluate the safety and dermal tolerability of a topical exosome-containing liquid in 10 healthy adult volunteers. The investigational liquid will be applied to a small defined area of intact skin. A vehicle liquid without exosomes may be applied to a matched contralateral skin site as a control. The study will assess local skin reactions, systemic adverse events, vital signs, clinical laboratory parameters, and feasibility of topical administration. No burn wound or artificial skin wound will be induced in participants in this Phase 1 safety study.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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.
Current acute illness, fever, or active infection.
Known autoimmune disease, immunodeficiency, or current systemic immunosuppressive therapy.
Trial design
Treatments tested in this trial
- Exosome-Containing Liquid
- Vehicle Liquid
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov