Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bilateral Nasolabial Fold Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active

Group Type EXPERIMENTAL

Autologous Human Fibroblast (azficel-T)

Intervention Type BIOLOGICAL

1. Collection of 3 mm post auricular skin punch biopsies.
2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

1. Collection of 3 mm post auricular skin punch biopsies.
2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.

Interventions

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Autologous Human Fibroblast (azficel-T)

1. Collection of 3 mm post auricular skin punch biopsies.
2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.

Intervention Type BIOLOGICAL

Placebo

1. Collection of 3 mm post auricular skin punch biopsies.
2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.

Intervention Type BIOLOGICAL

Other Intervention Names

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LAVIV

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No