Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
1 other identifier
interventional
203
1 country
7
Brief Summary
The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM compared with placebo when administered to bilateral nasolabial fold wrinkles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2006
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
March 13, 2012
CompletedMarch 13, 2012
February 1, 2012
1.8 years
March 27, 2008
February 9, 2012
February 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Subject Wrinkle Assessment Responders
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Baseline (prior to first treatment) and 6 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
Baseline (prior to first treatment) and 6 months after last treatment
Secondary Outcomes (2)
Subject Wrinkle Assessment Responders
Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Study Arms (2)
Active
EXPERIMENTALControl
PLACEBO COMPARATORInterventions
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.
1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.
Eligibility Criteria
You may qualify if:
- Subject is at least 18 years of age
- Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
- Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
- Ability to comply with the study requirements
- Negative pregnancy test (Females)
- Healthy post-auricular skin for biopsy
You may not qualify if:
- Excessive dermatochalasis of the treatment area
- Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
- Total area to be treated exceeds 20 cm in length
- Physical attributes which may prevent assessment or treatment as judged by the evaluator
- Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
- Previous treatment with the sponsor's product
- History of active autoimmune disease or organ transplantation
- Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
- Active or chronic skin disease
- Known genetic disorders affecting fibroblasts or collagen
- Active systemic infection
- Requires chronic antibiotic or steroidal therapy
- Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
- Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
- Known allergic reactions to agents used in preparation of treatment
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama, United States
Silverburg Surgical & Medical Group
Newport Beach, California, 92660, United States
Dermatology Research Institute, LLC
Coral Gables, Florida, United States
River North Dermatology and Dermatologic Surgery
Naperville, Illinois, United States
Aesthetic Solutions
Chapel Hill, North Carolina, United States
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina, United States
Center for Skin Research
Houston, Texas, United States
Results Point of Contact
- Title
- Kevin Hennegan
- Organization
- CBR International Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
October 1, 2006
Primary Completion
July 1, 2008
Study Completion
May 1, 2009
Last Updated
March 13, 2012
Results First Posted
March 13, 2012
Record last verified: 2012-02