Phase 2
N=50
Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
Facial Wrinkles and Creases
Bottom Line
View on ClinicalTrials.gov: NCT00654654 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Mar 2012
Primary outcome: Primary: Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment — 2; 5; 15; 11 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Human Fibroblasts (azficel-T) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Castle Creek Biosciences, LLC.
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment |
2; 5; 15; 11; 7; 1 | — |
| PRIMARY Independent Panel Global Improvement Assessment Compared to Baseline |
10; 29; 5; 0 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00654654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.