Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
This study has been completed.
Sponsor:
Fibrocell Technologies, Inc.
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00649428
First received: March 27, 2008
Last updated: February 9, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bilateral Nasolabial Fold Wrinkles |
Biological: Autologous Human Fibroblast (azficel-T) Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Fibrocell Technologies, Inc.:
Primary Outcome Measures:
- Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months post final treatment ] [ Designated as safety issue: No ]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.
- Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) and 6 months after last treatment ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Subject Wrinkle Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ] [ Designated as safety issue: No ]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.
- Evaluator Wrinkle Severity Assessment Responders [ Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment ] [ Designated as safety issue: No ]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.
| Enrollment: | 203 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active |
Biological: Autologous Human Fibroblast (azficel-T)
Other Name: LAVIV
|
| Placebo Comparator: Control |
Biological: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Excessive exposure to sun without adequate sun protection
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649428
Locations
| United States, Alabama | |
| Total Skin & Beauty Dermatology Center, PC | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Silverburg Surgical & Medical Group | |
| Newport Beach, California, United States, 92660 | |
| United States, Florida | |
| Dermatology Research Institute, LLC | |
| Coral Gables, Florida, United States | |
| United States, Illinois | |
| River North Dermatology and Dermatologic Surgery | |
| Naperville, Illinois, United States | |
| United States, North Carolina | |
| Aesthetic Solutions | |
| Chapel Hill, North Carolina, United States | |
| Dermatology, Laser & Vein Specialists of the Carolinas | |
| Charlotte, North Carolina, United States | |
| United States, Texas | |
| Center for Skin Research | |
| Houston, Texas, United States | |
Sponsors and Collaborators
Fibrocell Technologies, Inc.
More Information
No publications provided
| Responsible Party: | Fibrocell Technologies, Inc. |
| ClinicalTrials.gov Identifier: | NCT00649428 History of Changes |
| Other Study ID Numbers: | IT-R-005 |
| Study First Received: | March 27, 2008 |
| Results First Received: | February 9, 2012 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Fibrocell Technologies, Inc.:
|
Treatment of moderate to severe bilateral nasolabial fold wrinkles |
ClinicalTrials.gov processed this record on May 16, 2013