Clinical trial NCT00654654: Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Facial Wrinkles and Creases
Lead sponsor: Castle Creek Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2008-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
timeFrame: Baseline (prior to first treatment) compared to 6 months post last treatment
measure: Independent Panel Global Improvement Assessment Compared to Baseline
timeFrame: Baseline (prior to treatment) compared to 6 months post last treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Rhonda Rand, M.D., Inc.
state: California
city: Santa Monica
country: United States
facility: The Laser Institute for Dermatology
state: California
city: Orlando
country: United States
facility: Winter Park and Orlando Plastic Surgery
state: Florida
city: Wellesley
country: United States
facility: Dermatology Partners
state: Massachusetts
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
Study officials:
References: