A single centre open-label study to evaluate the tolerability and safety of a synthetic injectable soft tissue implant material (Family C Matrix) in the skin of normal volunteers.
Cosmetrend Pty Ltd
14 participants
Aug 1, 2008
Interventional
Conditions
Summary
2 RATIONALE Currently, although there are a wide variety of surgical mesh products and soft tissue implants commercially available, the ideal implant material has not yet been found. These types of products have been used for a wide variety of medical uses including but not limited to correction of wrinkles or other cosmetic enhancements, scars and bulking of tissue to treat incontinence. Synthetic polymer based technology offers the potential of a longer lasting more durable soft tissue implant. This pilot study is directed toward establishing the suitability of a implant material with Family C microspheres suspended in a hyaluronic acid gel matrix (Family C Matrix) as a possible soft tissue implant in man.
Eligibility
Inclusion Criteria8
- Participants 18 years of age or older, male or female, in generally good health.
- Participants willing and able to comply with the requirements of the study.
- Participants willing and able to comply with the follow-up requirements.
- Participants willing and able to give informed consent.
- Females must be post-menopausal, surgically sterile or willing to use a
- medically acceptable form of birth control during the study. Males must be
- sterile, surgically sterile or willing to use a medically acceptable form of birth
- control during the study
Exclusion Criteria17
- Participants who are pregnant, nursing or intend to become pregnant during the
- study period.
- 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 or
- nasal corticosteroids is acceptable.
- Participants who were or are currently being treated with any topical OTC drug or
- prescription therapy on their proximal arm test area within the past 3 months.
- Participants with skin findings or disease in the proposed implant area that could
- confound the interpretation of the reactivity of the implant sites.
- Participants with a history indicative of abnormal immune function (e.g. autoimmune
- diseases, HIV, cancer [other than non-melanoma skin cancer], etc.)
- Participants with known sensitivity to any of the Test Article materials.
- Participants with severe allergies manifested by a history of anaphylaxis.
- Participants are currently enrolled in an investigational drug or device study.
- Participants have received an investigational drug or treatment with an
- investigational device within 30 days prior to entering this study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Tolerability & safety of a new synthetic soft tissue implant material consisting of Family C microspheres in hyaluronic acid carrier in the skin of healthy volunteers. The Family C implant is a thermoplastic block copolymer produced from two long-chain methacrylic aliphatic esters and one short-chain acrylic aliphatic ester. At body temperature, the material is an elastomeric solid. The Family C test article proposed will be the same material currently under evaluation per protocol D73-2602-07, yet will be provided in a microsphere form, suspended in hyaluronic acid (HA), and injected into the dermis. The implants will be delivered via a standard syringe and needle, with the assistance of an additional investigational syringe driver device. This Family C co-polymer material is now being proposed for evaluation as an injectable matrix for use in soft tissue repair or augmentation. The material is presented as microspheres in a suspension of HA. At Screening Visit (up to 30 days before Visit 1), participants will be evaluated for eligibility per the inclusion/exclusion criteria and review of their medical and dermatological history. Eligible and willing participants will review and sign the informed consent form. At Baseline – Treatment Visit 1 (Day 1), participants from whom a signed, written informed consent has been obtained and study eligibility confirmed, will be designated to receive implantation with the Test Article. Each participant will be randomly assigned to two time points for biopsy evaluation (Day 30, 90, 180, 270 or 360) of the implant material prior to placement. Two implants (~ 0.1cc) will be administered intradermally within the designated region of the inner aspect of their proximal forearm (mid-humeral area), right or left side. At the Follow-Up Visits 2, 3, 4 5, 6, 7 and 8 (Day 8, 15, 30, 60, 90, 180 or 270) participants will return to the study site for evaluation and grading of the implant sites by the Investigator per protocol. Participants will return for their Procedure Visit 1 and 2 (@ two of the randomly assigned time points; Day 30, 90, 180, 270 or 360). Each participant will have two procedure visits to remove their two implants by the investigator. Thirty (30) days after the second Procedure Visit, participants will return for post excision evaluation of the test sites. The total duration of the trial is 15 months.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12608000003370