Clinical trial NCT00649428: Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bilateral Nasolabial Fold Wrinkles
Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Subject Wrinkle Assessment Responders
timeFrame: Baseline (prior to first treatment) and 6 months post final treatment
measure: Evaluator Wrinkle Severity Assessment Responders
timeFrame: Baseline (prior to first treatment) and 6 months after last treatment
Secondary outcomes:
measure: Subject Wrinkle Assessment Responders
timeFrame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
measure: Evaluator Wrinkle Severity Assessment Responders
timeFrame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin & Beauty Dermatology Center, PC
state: Alabama
city: Newport Beach
country: United States
facility: Silverburg Surgical & Medical Group
state: California
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
city: Naperville
country: United States
facility: River North Dermatology and Dermatologic Surgery
state: Illinois
city: Chapel Hill
country: United States
facility: Aesthetic Solutions
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas
state: North Carolina
city: Houston
country: United States
facility: Center for Skin Research
state: Texas
Study officials:
References: