Facial Wrinkles and CreasesPhase 2NCT00654654

Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

A Phase 2 study testing Autologous Human Fibroblasts (azficel-T) in people with Facial Wrinkles and Creases, run by Castle Creek Biosciences, LLC. at 5 sites in United States.

Completed

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

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Facial Wrinkles and Creases
What is being tested?: Autologous Human Fibroblasts (azficel-T)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 5 sitesUnited States
Study dates: Mar 2007to Jun 2008
Phase: Phase 2
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

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

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Rhonda Rand, M.D., Inc.
Beverly Hills, California, 90210
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Winter Park and Orlando Plastic Surgery
Orlando, Florida, 32804
The Laser Institute for Dermatology
Santa Monica, California, 90404
Dermatology Partners
Wellesley, Massachusetts, 02481

Other trials in United States

About this study

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

Conditions: Facial Wrinkles and Creases
Being tested: Autologous Human Fibroblasts (azficel-T)

What participants receive

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

Autologous Human Fibroblasts (azficel-T)Biological
Also called LAVIV
1. Collection of 3 mm biopsies
2. Two injection treatments of facial wrinkles and creases
3. Conduct of study assessments

Study groups in NCT00654654
Study group	Role	What they receive
Active	Experimental	Not described Receives: Biological: Autologous Human Fibroblasts (azficel-T)

What is being measured

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

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.
Measured: Baseline (prior to first treatment) compared to 6 months post last treatment
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.
Measured: Baseline (prior to treatment) compared to 6 months post last treatment

Timeline

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

Mar 2007Jun 2008

First posted9 Apr 2008 (estimated)
Study startMar 2007
Primary completionJun 2008
Study completionJun 2008

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 Facial Wrinkles and CreasesStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654654
Sponsor's protocol ID: IT-R-007
Status last verified: Feb 2012
First submitted: 3 Apr 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 Treatment of Facial Wrinkles and Creases
ClinicalTrials.gov ID: NCT00654654
Acronym / sponsor ID: IT-R-007
Conditions: Facial Wrinkles and Creases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Castle Creek Biosciences, LLC.Industry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 9 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 autologous human fibroblasts and placebo when administered to facial wrinkles and creases

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Active	Experimental	Biological: Autologous Human Fibroblasts (azficel-T)

Who may qualify

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

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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

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 Fibroblasts (azficel-T)Also: LAVIV1. Collection of 3 mm biopsies 2. Two injection treatments of facial wrinkles and creases 3. Conduct of study assessments	Biological	Active

Primary outcome

Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment
Time frame: 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
Time frame: 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.

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	50	43

Primary outcome: Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment

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

Measure	Autologous Fibroblasts n = 41
Change = -1 (worse)	2
Change = 0 (no change)	5
Change = +1 (better)	15
Change = +2 (better)	11
Change = +3 (better)	7
Change = +4 (better)	1

Population analysed: Number of subjects for whom data were available from the assessment visit, 6 months after the final treatment

Primary outcome: Independent Panel Global Improvement Assessment Compared to Baseline

Time frame: Baseline (prior to treatment) compared to 6 months post last treatment. Number. Unit: participants

Measure	Autologous Fibroblasts n = 44
No improvement	10
Mild improvement	29
Moderate improvement	5
Marked improvement	0

Population analysed: Number of patients for whom data were available

Adverse events

Time frame: Adverse event data were collected for six months after final study treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	2 of 50 (4%)	17 of 50 (34%)	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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Human Fibroblasts (azficel-T) in people with Facial Wrinkles and Creases, run by Castle Creek Biosciences, LLC. at 5 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 19 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 5 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment (time frame: Baseline (prior to first treatment) compared to 6 months post last 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 NCT00654654.

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.