Acne Scarring of the FacePhase 2/3NCT00642642

Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

A Phase 2/3 study testing Autologous Human Fibroblasts (azficel-T) in people with Acne Scarring of the Face, 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

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Trial summary

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acne Scarring of the Face
What is being tested?: Autologous Human Fibroblasts (azficel-T)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 122 participants
Where: 7 sitesUnited States
Study dates: Nov 2007to Mar 2009
Phase: Phase 2/3
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, between 18 years and 65 years of age.
Investigator assessment of the acne scarring on each cheek of moderate to severe.
A history of acne scarring for more than 3 years.
Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Who cannot join

Significant active acne.
Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
Presence of hypertrophic scars on the cheeks.
More than 20% of treatment area comprised of ice pick scars or sinus tracts
Treatment area per cheek is less than 9 cm x cm
Unilateral or unbalanced acne scar distribution.

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Physical attributes which prevent the assessment or treatment of the acne scars.
Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
Previous treatment with Isolagen TherapyTM.
Use of Isotretinoin within one year of enrollment into study.
Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
Disorders or drugs that increase bleeding or clotting.
Pregnant or lactating women or women trying to become pregnant during the study.
Excessive exposure to sun.
Smoking more than ½ pack of cigarettes per day.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Brighton Medical Corporation
Beverly Hills, California, 90210
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Dermatology Research Institute, LLC
Coral Gables, Florida, 33146
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030
Sadick Dermatology
New York, New York, 10021
Therapeutics Clinical Research
San Diego, California, 92123
The Laser Institute for Dermatology
Santa Monica, California, 90404

Other trials in United States

About this study

Official title: A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring

The purpose of this study is to evaluate the safety profile and the treatment effect of Isolagen TherapyTM and placebo when administered to facial acne scars.

Conditions: Acne Scarring of the Face
Being tested: Autologous Human Fibroblasts (azficel-T), Placebo
Keywords: Acne
Medical subject headings: Acne Vulgaris

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 post auricular skin punch biopsies.
2. Administration of 3 study treatments administered 14 ± 7 days apart.
PlaceboBiological
1. Collection of 3 mm post auricular skin punch biopsies.
2. Administration of 3 study treatments administered 14 ± 7 days apart.

Study groups in NCT00642642
Study group	Role	What they receive
Double blinded active	Experimental	Subject will receive autologous fibroblast treatment on either their left or right side of their face Receives: Biological: Autologous Human Fibroblasts (azficel-T)
Double blinded placebo	Placebo comparator	Subject will receive placebo treatment on the opposite side of the face from active treatment Receives: Biological: Placebo

What is being measured

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

Evaluator Live Acne Scarring Assessment Responders
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Measured: Baseline (prior to first treatment) and four months after last treatment
Subject Live Acne Scarring Assessment Responders
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.
Measured: Baseline (prior to first treatment) and four months after last treatment

Secondary outcomes (2)

Evaluator Live Acne Scarring Assessment Responders
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Measured: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Subject Live Acne Scarring Assessment Responders
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.
Measured: Baseline (prior to first treatment) compared to one, two, and three months after last treatment

Timeline

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

Nov 2007Mar 2009

First posted25 Mar 2008 (estimated)
Study startNov 2007
Primary completionMar 2009
Study completionMar 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 Acne Scarring of the FaceStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642642
Sponsor's protocol ID: IT-A-008
Status last verified: Jul 2013
First submitted: 19 Mar 2008
Last updated: 21 Aug 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
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Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
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Active, not recruitingPhase 2
A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars
Cicatrix
Not yet recruiting
Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars
Acne Scars - Atrophic
Recruiting
PRP Plus Fractional CO₂ Laser for Acne Scars
Post-Acne Atrophic Scars, Carbon Dioxide Lasers

All Acne Scarring of the Face trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II/III Double-Blind, Randomized, Placebo-Controlled Trial of the Safety and Efficacy of Isolagen Therapy in the Treatment of Moderate to Sever Facial Acne Scarring
ClinicalTrials.gov ID: NCT00642642
Acronym / sponsor ID: IT-A-008
Conditions: Acne Scarring of the Face
Keywords: Acne
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: Castle Creek Biosciences, LLC.Industry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Posted 21 Aug 2013

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 and placebo when administered to facial acne scars.

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
Double blinded active	Experimental	Biological: Autologous Human Fibroblasts (azficel-T)Subject will receive autologous fibroblast treatment on either their left or right side of their face
Double blinded placebo	Placebo comparator	Biological: PlaceboSubject will receive placebo treatment on the opposite side of the face from active treatment

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, between 18 years and 65 years of age.
Investigator assessment of the acne scarring on each cheek of moderate to severe.
A history of acne scarring for more than 3 years.
Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Key exclusion criteria (15 listed)

Significant active acne.
Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
Presence of hypertrophic scars on the cheeks.
More than 20% of treatment area comprised of ice pick scars or sinus tracts
Treatment area per cheek is less than 9 cm x cm

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 post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.	Biological	Double blinded active
Placebo1. Collection of 3 mm post auricular skin punch biopsies. 2. Administration of 3 study treatments administered 14 ± 7 days apart.	Biological	Double blinded placebo

Primary outcome

Evaluator Live Acne Scarring Assessment Responders
Time frame: Baseline (prior to first treatment) and four months after last treatment
Subjects who improved by 1 point or more on the Evaluator Live Acne Scarring Assessment (ELASA), as assessed by the evaluating Investigator, are counted as responders. On the ELASA scale, a score of 0 (Clear) is best and a score of 4 (Severe) is worst.
Subject Live Acne Scarring Assessment Responders
Time frame: Baseline (prior to first treatment) and four months after last treatment
Cheeks that improved by at least two points on the Subject Live Acne Scarring Assessment (SLASA) as scored by the subject were considered responders. On the SLASA scale, a score of -2 (Very Dissatisfied) was worst and a score of 2 (Very Satisfied) was best.

2 secondary outcomes

Evaluator Live Acne Scarring Assessment Responders
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Subject Live Acne Scarring Assessment Responders
Time frame: Baseline (prior to first treatment) compared to one, two, and three months after last treatment

Results and safety

Results posted to the registry on 21 Aug 2013, 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 and Placebo	122	109

Primary outcome: Evaluator Live Acne Scarring Assessment Responders

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

Measure	Autologous Fibroblasts Cheeks n = 109	Placebo Cheeks n = 109
Value	64	46

Autologous Fibroblasts Cheeks vs Placebo Cheeks: p = 0.0109, McNemar

Population analysed: Analysis population was the ITT population, defined as subjects for whom product could be produced and who were randomized to study treatment, whether or not all study treatments are actually received.

Primary outcome: Subject Live Acne Scarring Assessment Responders

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

Measure	Autologous Fibroblast Cheeks n = 109	Placebo Cheeks n = 109
Value	47	20

Autologous Fibroblast Cheeks vs Placebo Cheeks: p <0.0001, McNemar

Population analysed: Analysis was performed on the ITT population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of patient biopsy through the final study visit, four months after final study treatment (five months after first study treatment).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Autologous Fibroblast Cheeks	0 of 122 (0%)	11 of 122 (9%)	Not reported
Placebo Cheeks	0 of 122 (0%)	10 of 122 (8.2%)	Not reported
Non-treatment Area Adverse Events	1 of 122 (0.8%)	1 of 122 (0.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acne Scarring of the Face

Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
Recruiting
Evaluation of Juläine (TM) for the Treatment of Atrophic Facial Acne Scars
Acne Scars
Active, not recruitingPhase 2
A Pilot Study Testing Fractional Radiofrequency Versus Fractional Photothermolysis for the Treatment of Acne Scars
Cicatrix
Not yet recruiting
Efficacy and Safety of Combined Nanofat Injection With Either Platelet Rich Fibrin or Microneedling Versus Nanofat Injection Alone in the Treatment of Facial Atrophic Post Acne Scars
Acne Scars - Atrophic
Recruiting
PRP Plus Fractional CO₂ Laser for Acne Scars
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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 2/3 study testing Autologous Human Fibroblasts (azficel-T) in people with Acne Scarring of the Face, 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 4 inclusion and 15 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 21 Aug 2013. 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 combined 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.

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 21 Aug 2013). 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?

Evaluator Live Acne Scarring Assessment Responders (time frame: Baseline (prior to first treatment) and four months after 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 NCT00642642.

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 21 Aug 2013.