Healthy Male and Female Subjects
Conditions
Keywords
Histological Analysis, Dermal Filler
Brief summary
Single-center, exploratory study assessing the safety and histological presentation of CelluJuve® injected into the brachium of healthy volunteers
Detailed description
At Visit 1 (Baseline), all subjects will receive injections (0.2mL bolus) of CelluJuve® into the proximal medial aspect of the brachium of their non dominant arm. The volume per microbolus of CelluJuve® into a single injection site is 0.2 mL. All injections will be performed using the same type/brand of 25G x 1/2 (0.50x13 mm) needle. One 5-mm punch biopsy will be taken from injection sites at 2 weeks, 1 month and 3 months. Punch biopsy samples will be fixed in formol before being frozen or dehydrated, impregnated in paraffin, and embedded. Prepared samples will then be cut into 4 µm sections and analyzed for general morphology, immunostaining, and immunogenicity. Analysis will be performed at the epidermis, papillary dermis, and lower reticular dermis depending on the extracellular matrix component of interest. Safety will be assessed through AE reporting, study diaries, and concomitant medications.
Interventions
DEVICECelluJuve®
CelluJuve® injected into upper brachium
Sponsors
ethica Clinical Research Inc.
Spiderwort Biotechnologies Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female volunteers of any race between 30 and 65 years of age. 2. Female subjects of childbearing potential must have a negative UPT at Visit 1 and practice a reliable method of contraception throughout the study. 3. Healthy skin in the study treatment area and free of conditions or diseases that could interfere with study evaluations. 4. Subjects willing to receive microbolus injections of CelluJuve® into the proximal medial aspect of the brachium of their non-dominant arm, and willing to have one 5-mm cutaneous punch biopsy taken from each injection site. 5. Able to follow study instructions and complete all required visits. 6. Signed ICF and Photographic Release.
Exclusion criteria
1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable contraception. 2. Study staff or close relative to study staff (e.g., parents, children, siblings, or spouse). 3. Subjects with known prolonged bleeding times due to disease or ongoing regimen use of anticoagulants (e.g., warfarin). 4. Acute or chronic skin disease, inflammation, or related conditions, cancerous or precancerous lesions near the treatment area. 5. Presence of any skin pathology or condition that could interfere with the evaluation of the treatment areas, worsen due to study treatment, or require interfering topical, systemic, or surgical therapy. 6. Known history of medical or psychiatric conditions that may increase the risk associated with study participation or may interfere with interpretation of study results or compliance of the subject and could make the subject inappropriate for study entry. 7. Known history of allergic/anaphylactic reactions to any of the components of CelluJuve® including known sensitivity to cellulose, porcine gelatin, or to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock. 8. Known history of malignancy (excluding non-melanoma skin cancer) within the past 3 years. 9. Known history of systemic granulomatous diseases active or inactive (e.g., Sarcoid, Wegener's disease, TB, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.). 10. Known history or evidence of keloid scarring, susceptibility to keloid formation or hypertrophic scarring, or delayed healing activity. 11. Known history or presence of severe chronic systemic diseases, including but not limited to, poorly controlled diabetes mellitus (all types), congestive heart failure, severe liver disease, severe kidney disease, and others as judged by the Investigator. 12. Known history or presence of any autoimmune or connective tissue disease, receiving treatment with immunomodulating therapy, or is immunocompromised or immunosuppressed. 13. Known history of clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 14. Undergoing, or planning to undergo, radiation or ultrasound therapy in the treatment area. 15. Unwilling to adhere to medication restrictions for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histological assessment of biopsies - general morphology | 3 months | Assessment of general morphology (e.g., Masson's trichrome) |
| Histological assessment of biopsies - immunostaining | 3 months | Assessment of immunostaining (e.g., collagen, elastin, etc.) |
| Histological assessment of biopsies - immunogenicity | 3 months | Assessment of immunogenicity (e.g., inflammatory markers, cytokines, etc.) |
Countries
Canada
Outcome results
None listed