A SINGLE CENTER OPEN-LABEL PILOT STUDY TO EVALUATE THE TOLERABILITY AND SAFETY OF A SYNTHETIC SOFT TISSUE IMPLANT MATERIAL IN THE SKIN OF NORMAL VOLUNTEERS

Phase 1

Withdrawn

• Conditions: Tolerability and safety of a new synthetic soft tissue implant material for soft tissue augmentation in healthy volunteers.; Surgery - Other surgery

• Registration Number: ACTRN12607000223437
• Lead Sponsor: COSMETREND PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified