Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

Castle Creek Biosciences

Status and phase: Completed; Phase 2

Conditions: Facial Wrinkles and Creases

Treatments: Biological: Autologous Human Fibroblasts (azficel-T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00654654

IT-R-007

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile and the treatment effect of autologous human fibroblasts and placebo when administered to facial wrinkles and creases

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, at least 18 years of age
• High Investigator wrinkle severity assessment score
• Subject assessment of dissatisfaction of facial appearance
• Provide written informed consent and comply with the study requirements
• Negative pregnancy test at screening visit
• Healthy, non-scarred skin for biopsy

Exclusion criteria

• Low Investigator wrinkle severity assessment score
• Subject assessment of satisfaction of facial appearance
• Physical attributes which prevent the assessment or treatment of the facial wrinkles
• Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
• Previous treatment with Isolagen Therapy
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, receiving active treatment
• History of pigmentary disorders which can affect the face
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain cosmetic treatments & procedures
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Pregnant or lactating women or women trying to become pregnant
• Known allergic reaction to components of study treatment and/or study injection procedure
• Excessive exposure to sun or sunburn in the post-auricular area
• Subject has any disorder that may prevent compliance
• Subject who is part of the study staff, a family member or friend

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Active

Experimental group

Treatment:

Biological: Autologous Human Fibroblasts (azficel-T)