Safety and Efficacy Study of Isolagen Therapy in the Treatment of Nasolabial Fold Wrinkles - Full Text View

Sponsored by:	Isolagen Technologies, Inc.
Information provided by:	Isolagen Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00655356

Purpose

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.

Condition	Intervention	Phase
Bilateral Nasolabial Fold Wrinkles	Biological: Autologous Human Fibroblasts (Isolagen TherapyTM) Biological: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Further study details as provided by Isolagen Technologies, Inc.:

Primary Outcome Measures:

Subject and Evaluator assessment of wrinkles compared to baseline [ Time Frame: 6 months post Treatment 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject and Evaluator assessment of wrinkles compared to baseline [ Time Frame: For all study visits up through 6 months post Treatment 3 ] [ Designated as safety issue: No ]

Enrollment:	218
Study Start Date:	November 2006
Study Completion Date:	May 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Experimental	Biological: Autologous Human Fibroblasts (Isolagen TherapyTM) Collection of 3 mm post auricular skin punch biopsies. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.
Placebo: Placebo Comparator	Biological: Placebo Collection of 3 mm post auricular skin punch biopsies. Three treatment visits with injections administered 5 ± 1 weeks apart on each side of the face.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655356

Locations

United States, California
Brighton Medical Corporation
Beverly Hills, California, United States, 91210
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Georgia
Gwinnett Clinical Research Center
Snellville, Georgia, United States, 30078
United States, Texas
Dermatology San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Institute of Anti Aging Research
Virginia Beach, Virginia, United States, 23454

Sponsors and Collaborators

Isolagen Technologies, Inc.

More Information

No publications provided

Responsible Party:	Isolagen Technologies, Inc. ( John Maslowski, M.S. / VP Operations )
Study ID Numbers:	IT-R-006
Study First Received:	March 31, 2008
Last Updated:	May 12, 2009
ClinicalTrials.gov Identifier:	NCT00655356 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Isolagen Technologies, Inc.:

Treatment of moderate to severe bilateral nasolabial fold wrinkles

ClinicalTrials.gov processed this record on September 09, 2009