Phase 3
N=203
Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
Bilateral Nasolabial Fold Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT00649428 ↗Enrolled (actual)
203
Serious AEs
3.0%
Results posted
Mar 2012
Primary outcome: Primary: Subject Wrinkle Assessment Responders — 57; 31 participants — p=.00001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Autologous Human Fibroblast (azficel-T) (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Castle Creek Biosciences, LLC.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Wrinkle Assessment Responders |
38; 23; 49; 25; 48; 26 | — |
| PRIMARY Evaluator Wrinkle Severity Assessment Responders |
33; 7 | <.00001 sig |
| SECONDARY Subject Wrinkle Assessment Responders |
38; 23; 49; 25; 48; 26 | — |
| SECONDARY Evaluator Wrinkle Severity Assessment Responders |
33; 7 | <.00001 sig |
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
Data sourced from ClinicalTrials.gov (NCT00649428). 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.