Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Completed · Phase 3 · Has a placebo group

Conditions studied: Bilateral Nasolabial Fold Wrinkles

In brief

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.

Key facts

Study ID

NCT00649428

Run by

Castle Creek Biosciences, LLC.

People needed

203

Starts

2006-10-01

Expected to finish

2009-05-01

Last updated by the study team

2012-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Excessive exposure to sun without adequate sun protection

Where it is running

• Total Skin & Beauty Dermatology Center, PC — Birmingham, Alabama, United States
• Silverburg Surgical & Medical Group — Newport Beach, California, 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

Full record on ClinicalTrials.gov

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