None listed
Conditions
Brief summary
The primary purpose of this pilot study is to assess the clinical tolerability and safety of a new synthetic soft tissue implant material in the skin of healthy volunteers.
Interventions
Each participant will receive two (diameter - 4.4 mm, thickness ~1 to 2 mm) Test Article implants, placed at the mid-to-deep dermal layer and/or superficial fat junction of their skin. The implant sites will be selected by the investigator within the anatomic region of the torso (superior pelvic rim to the apex of the shoulders) of each participant. The skin implant material will be placed by making a small single incision, up to 1.5 cm in length to the level of the mid-to-deep dermis or super
Each participant will receive two (diameter - 4.4 mm, thickness ~1 to 2 mm) Test Article implants, placed at the mid-to-deep dermal layer and/or superficial fat junction of their skin. The implant sites will be selected by the investigator within the anatomic region of the torso (superior pelvic rim to the apex of the shoulders) of each participant. The skin implant material will be placed by making a small single incision, up to 1.5 cm in length to the level of the mid-to-deep dermis or superficial fat junction, as appropriate. The implant will then be placed into the incision pocket and sutured closed. The implants will remain in place for 90 days with follow up visits at days 7, 14, 30, 60 for evaluation and grading of site per protocol. At day 90 the implants will be excised. All specimens will be submitted for histologic examination. A final visit will occur 30 days post excision for evaluation of the test sites.
Sponsors
COSMETREND PTY LTD
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. In generally good health2. Participants willing and able to comply with the requirements of the study3. Participants willing and able to comply with the follow-up requirements4. Participants willing and able to give informed consent5. Females must be post-menopausal, surgically sterile or willing to use a medically acceptable form of birth control during the study. Males must be willing to use a medically acceptable form of birth control during the study.
Exclusion criteria
1. Participants who are pregnant, nursing or intend to become pregnant during the study period2. Participants who were or are currently being treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids within the past 3 months. The use of stable doses of inhaled corticosteroids is acceptable.3. Participants who were or are currently being treated with any topical Over The Counter (OTC) drug or prescription therapy on their torso within the past 3 months.4. Participants with skin findings or disease in the proposed implant area that could confound the interpretation of the reactivity of the implant sites.5. Participants with a history indicative of abnormal immune function (e.g. auto-immune diseases, HIV, cancer [other than non-melanoma skin cancer], etc.)6. Participants with known sensitivity to any of the Test Article materials.7. Participants with severe allergies manifested by a history of anaphylaxis.8. Participant is currently enrolled in an investigational drug or device study. 9. Participant has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
Outcome results
None listed