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 Ltd0 个研究点目标入组 14 人开始时间: 2008年1月7日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Participants 18 years of age or older, male or female, in generally good health.
•2. Participants willing and able to comply with the requirements of the study.
•3. Participants willing and able to comply with the follow-up requirements.
•4. Participants willing and able to give informed consent.
•5. 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

•1. Participants who are pregnant, nursing or intend to become pregnant during the
•study period.
•2. 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.
•3. 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.
•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. autoimmune
•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. Participants are currently enrolled in an investigational drug or device study.
•9. Participants have received an investigational drug or treatment with an
•investigational device within 30 days prior to entering this study.

发起方

Cosmetrend Pty Ltd