Facial Wrinkles and Creases
Conditions
Brief 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
Interventions
BIOLOGICALAutologous Human Fibroblasts (azficel-T)
1. Collection of 3 mm biopsies 2. Two injection treatments of facial wrinkles and creases 3. Conduct of study assessments
Sponsors
Castle Creek Biosciences, LLC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Baseline (prior to first treatment) compared to 6 months post last treatment | Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best. |
| Independent Panel Global Improvement Assessment Compared to Baseline | Baseline (prior to treatment) compared to 6 months post last treatment | An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited between 22 March 2007 and 8 August 2007
Participants by arm
| Arm | Count |
|---|---|
| Autologous Fibroblasts Patients received treatment with autologous fibroblasts to multiple facial regions | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Autologous Fibroblasts |
|---|---|
| Age Continuous | 47.4 years STANDARD_DEVIATION 7 |
| Race/Ethnicity, Customized Non-white participants | 2 Participants |
| Race/Ethnicity, Customized White participants | 48 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 50 |
| serious Total, serious adverse events | 2 / 50 |
Outcome results
Primary
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
Subject Wrinkle Assessment was a five point ordinal scale that assessed the subject's assessment of the appearance of their face. A score of -2 (very dissatisfied) was the worst and a score of +2 (very satisfied) was the best.
Time frame: Baseline (prior to first treatment) compared to 6 months post last treatment
Population: Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = -1 (worse) | 2 participants |
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = 0 (no change) | 5 participants |
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = +1 (better) | 15 participants |
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = +2 (better) | 11 participants |
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = +3 (better) | 7 participants |
| Autologous Fibroblasts | Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment | Change = +4 (better) | 1 participants |
Primary
Independent Panel Global Improvement Assessment Compared to Baseline
An independent panel of physicians reviewed photographs of subjects at baseline and 6 months after final study treatment and provided a score for improvement in appearance on the Global Improvement Assessment. The Global Improvement Assessment was a four point ordinal scale with 0 (No improvement) as the worst score and 3 (Marked Improvement) the best.
Time frame: Baseline (prior to treatment) compared to 6 months post last treatment
Population: Number of patients for whom data were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Autologous Fibroblasts | Independent Panel Global Improvement Assessment Compared to Baseline | No improvement | 10 participants |
| Autologous Fibroblasts | Independent Panel Global Improvement Assessment Compared to Baseline | Mild improvement | 29 participants |
| Autologous Fibroblasts | Independent Panel Global Improvement Assessment Compared to Baseline | Moderate improvement | 5 participants |
| Autologous Fibroblasts | Independent Panel Global Improvement Assessment Compared to Baseline | Marked improvement | 0 participants |