- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00649428
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
February 9, 2012 updated by: Castle Creek Biosciences, LLC.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
203
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Total Skin & Beauty Dermatology Center, PC
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California
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Newport Beach, California, United States, 92660
- Silverburg Surgical & Medical Group
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Florida
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Coral Gables, Florida, United States
- Dermatology Research Institute, LLC
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Illinois
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Naperville, Illinois, United States
- River North Dermatology and Dermatologic Surgery
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North Carolina
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Chapel Hill, North Carolina, United States
- Aesthetic Solutions
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Charlotte, North Carolina, United States
- Dermatology, Laser & Vein Specialists of the Carolinas
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Texas
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Houston, Texas, United States
- Center for Skin Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active
|
Other Names:
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Placebo Comparator: Control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Wrinkle Assessment Responders
Time Frame: Baseline (prior to first treatment) and 6 months post final treatment
|
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.
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Baseline (prior to first treatment) and 6 months post final treatment
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Evaluator Wrinkle Severity Assessment Responders
Time Frame: Baseline (prior to first treatment) and 6 months after last treatment
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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.
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Baseline (prior to first treatment) and 6 months after last treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Wrinkle Assessment Responders
Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
|
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) compared to 3rd treatment visit, 2 and 4 months post final treatment
|
Evaluator Wrinkle Severity Assessment Responders
Time Frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
|
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) compared to 3rd treatment visit, 2 and 4 months post final treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 27, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
March 13, 2012
Last Update Submitted That Met QC Criteria
February 9, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- IT-R-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bilateral Nasolabial Fold Wrinkles
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Castle Creek Biosciences, LLC.CompletedBilateral Nasolabial Fold WrinklesUnited States
-
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Taipei Medical University HospitalTaipei Medical University; Panion & BF Biotech Inc.RecruitingNasolabial Fold WrinklesTaiwan
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Bausch Health Americas, Inc.CompletedNasolabial Fold WrinklesUnited States
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Bausch Health Americas, Inc.CompletedNasolabial Fold WrinklesUnited States
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Galderma R&DCompletedWrinkles | Nasolabial Fold Contour DeficienciesUnited States
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Medy-ToxCompletedNasolabial FoldKorea, Republic of
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