Bilateral Nasolabial Fold WrinklesPhase 3NCT00649428

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

A Phase 3 study testing Autologous Human Fibroblast (azficel-T) in people with Bilateral Nasolabial Fold Wrinkles, run by Castle Creek Biosciences, LLC. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bilateral Nasolabial Fold Wrinkles
What is being tested?: Autologous Human Fibroblast (azficel-T)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 203 participants
Where: 7 sitesUnited States
Study dates: Oct 2006to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Total Skin & Beauty Dermatology Center, PC
Birmingham, Alabama
Aesthetic Solutions
Chapel Hill, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas
Charlotte, North Carolina
Dermatology Research Institute, LLC
Coral Gables, Florida
Center for Skin Research
Houston, Texas
River North Dermatology and Dermatologic Surgery
Naperville, Illinois
Silverburg Surgical & Medical Group
Newport Beach, California, 92660

Other trials in United States

About this study

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.

Conditions: Bilateral Nasolabial Fold Wrinkles
Being tested: Autologous Human Fibroblast (azficel-T), Placebo
Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous Human Fibroblast (azficel-T)Biological
Also called LAVIV
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.
PlaceboBiological
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.

Study groups in NCT00649428
Study group	Role	What they receive
Active	Experimental	Not described Receives: Biological: Autologous Human Fibroblast (azficel-T)
Control	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subject Wrinkle Assessment Responders
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Measured: Baseline (prior to first treatment) and 6 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
Measured: Baseline (prior to first treatment) and 6 months after last treatment

Secondary outcomes (2)

Subject Wrinkle Assessment Responders
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Measured: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.
Measured: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006May 2009

First posted1 Apr 2008 (estimated)
Study startOct 2006
Primary completionJul 2008
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bilateral Nasolabial Fold WrinklesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00649428
Sponsor's protocol ID: IT-R-005
Status last verified: Feb 2012
First submitted: 27 Mar 2008
Last updated: 13 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles
ClinicalTrials.gov ID: NCT00649428
Acronym / sponsor ID: IT-R-005
Conditions: Bilateral Nasolabial Fold Wrinkles
Keywords: Treatment of moderate to severe bilateral nasolabial fold wrinkles
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Castle Creek Biosciences, LLC.Industry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Jul 2008 (actual)
Study completion: May 2009 (actual)
First posted: 1 Apr 2008 (estimated)
Results: Posted 13 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Biological: Autologous Human Fibroblast (azficel-T)
Control	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous Human Fibroblast (azficel-T)Also: LAVIV1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection treatments administered 5 ± 1 weeks apart on each side of the face.	Biological	Active
Placebo1. Collection of 3 mm post auricular skin punch biopsies. 2. Three injection visits administered 5 ± 1 weeks apart on each side of the face.	Biological	Control

Primary outcome

Subject Wrinkle Assessment Responders
Time frame: Baseline (prior to first treatment) and 6 months post final treatment
A two point improvement on the Subject's live assessment of the wrinkles of the lower part of the face as compared to baseline on the Subject Wrinkle Assessment was considered a responder. The Subject Wrinkle Assessment scale was a five point scale with a score of -2 (Very Dissatisfied) being the worst and a score of +2 (Very Satisfied) being the best.
Evaluator Wrinkle Severity Assessment Responders
Time frame: Baseline (prior to first treatment) and 6 months after last treatment
A responder was defined as a two point improvement on the blinded Evaluator's live assessment of each of the bilateral nasolabial fold wrinkles at rest using the 6-point ordinal Lemperle Wrinkle Severity Scale. On the Lemperle scale, a score of 5 (Very Deep Wrinkle) is worst and a score of 0 (No Visible Wrinkle) is best.

2 secondary outcomes

Subject Wrinkle Assessment Responders
Time frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment
Evaluator Wrinkle Severity Assessment Responders
Time frame: Baseline (prior to first treatment) compared to 3rd treatment visit, 2 and 4 months post final treatment

Results and safety

Results posted to the registry on 13 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Autologous Fibroblasts	100	80
Placebo	103	88

Primary outcome: Subject Wrinkle Assessment Responders

Time frame: Baseline (prior to first treatment) and 6 months post final treatment. Number. Unit: participants

Measure	Autologous Fibroblast n = 100	Placebo n = 103
Value	57	31

Autologous Fibroblast vs Placebo: p = .00001, Cochran-Mantel-Haenszel

Population analysed: Analysis population was the ITT population, defined as all randomized subjects.

Primary outcome: Evaluator Wrinkle Severity Assessment Responders

Time frame: Baseline (prior to first treatment) and 6 months after last treatment. Number. Unit: participants

Measure	Autologous Fibroblasts n = 100	Placebo n = 103
Value	33	7

Autologous Fibroblasts vs Placebo: p <.00001, Cochran-Mantel-Haenszel

Population analysed: Analysis population was the ITT population, defined as all randomized subjects.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the baseline visit through the final study visit, 6 months after final study treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous Fibroblasts	2 of 100 (2%)	32 of 100 (32%)	Not reported
Placebo	4 of 103 (3.9%)	34 of 103 (33%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Autologous Human Fibroblast (azficel-T) in people with Bilateral Nasolabial Fold Wrinkles, run by Castle Creek Biosciences, LLC. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Wrinkle Assessment Responders (time frame: Baseline (prior to first treatment) and 6 months post final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00649428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.