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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00642642
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : August 21, 2013
Last Update Posted : August 21, 2013
Sponsor:
Information provided by (Responsible Party):
Fibrocell Technologies, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Scarring of the Face
Interventions Biological: Autologous Human Fibroblasts (azficel-T)
Biological: Placebo
Enrollment 122
Recruitment Details Patients were recruited between 7 Nov 2007 and 6 March 2008
Pre-assignment Details Patients were enrolled and biopsied for manufacture of study product. Patients for whom study product could not be manufactured were excluded from the Intent to Treat (ITT) population.
Arm/Group Title Autologous Fibroblasts and Placebo
Hide Arm/Group Description Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
Period Title: Biopsy & Product Manufacture
Started 122
Completed 109 [1]
Not Completed 13
[1]
Patients biopsied and for whom study product could be produced are considered completed
Period Title: Treatment & Follow Up
Started 109
Completed 92
Not Completed 17
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             5
Lost to Follow-up             10
Arm/Group Title Autologous Fibroblasts and Placebo
Hide Arm/Group Description Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
Overall Number of Baseline Participants 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
<=18 years
0
   0.0%
Between 18 and 65 years
109
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
41.7  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
62
  56.9%
Male
47
  43.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Hispanic or Latino
27
  24.8%
Not Hispanic or Latino
82
  75.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
American Indian or Alaska Native
1
   0.9%
Asian
5
   4.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
8
   7.3%
White
78
  71.6%
More than one race
0
   0.0%
Unknown or Not Reported
17
  15.6%
1.Primary Outcome
Title Evaluator Live Acne Scarring Assessment Responders
Hide Description 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.
Time Frame Baseline (prior to first treatment) and four months after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Autologous Fibroblasts Cheeks Placebo Cheeks
Hide Arm/Group Description:
Cheeks treated with autologous fibroblasts (azficel-T)
Cheeks treated with placebo solution
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: Participants
64 46
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autologous Fibroblasts Cheeks, Placebo Cheeks
Comments

Null hypothesis: no difference in the response rates between the two treatment arms.

Statistical test: McNemar’s paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.

Assumptions for power calculations:

Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks & 50% correlation between endpoints

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments a priori threshold for statistical significance was 0.05
Method McNemar
Comments Paired test of proportions
2.Primary Outcome
Title Subject Live Acne Scarring Assessment Responders
Hide Description 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.
Time Frame Baseline (prior to first treatment) and four months after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population
Arm/Group Title Autologous Fibroblast Cheeks Placebo Cheeks
Hide Arm/Group Description:
Cheeks treated with autologous fibroblasts
Cheeks treated with placebo solution
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: Cheeks
47 20
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Autologous Fibroblast Cheeks, Placebo Cheeks
Comments

Null hypothesis: no difference in the response rates between the two treatment arms.

Statistical test: McNemar’s paired test of proportions Significance level: two sided alpha of 0.05 for each of the two co-primary endpoints.

Assumptions for power calculations:

Response rate for azficel-T treated cheek = 40% Response rate for placebo treated cheek = 20% 10% dropout rate; dropouts counted as failures. Low correlation between cheeks & 50% correlation between endpoints

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments a priori threshold for statistical significance = 0.05
Method McNemar
Comments paired test of proportions
3.Secondary Outcome
Title Evaluator Live Acne Scarring Assessment Responders
Hide Description 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.
Time Frame Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Number of cheeks for analysis was the ITT population
Arm/Group Title Autologous Fibroblasts Cheeks Placebo Cheeks
Hide Arm/Group Description:
Cheeks treated with autologous fibroblasts (azficel-T)
Cheeks treated with placebo solution
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: Participants
1 Month Post Treatment 54 32
2 Months Post Treatment 56 41
3 Months Post Treatment 57 47
4.Secondary Outcome
Title Subject Live Acne Scarring Assessment Responders
Hide Description 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.
Time Frame Baseline (prior to first treatment) compared to one, two, and three months after last treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the ITT population
Arm/Group Title Autologous Fibroblast Cheeks Placebo Cheeks
Hide Arm/Group Description:
Cheeks randomized to receive autologous fibroblast treatment
Cheeks randomized to receive placebo treatment
Overall Number of Participants Analyzed 109 109
Measure Type: Number
Unit of Measure: Cheeks
1 Month Post Treatment 34 10
2 Months Post Treatment 41 15
3 Months Post Treatment 43 20
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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous Fibroblast Cheeks Placebo Cheeks Non-treatment Area Adverse Events
Hide Arm/Group Description Cheeks randomized to receive autologous fibroblast treatment Cheeks randomized to receive placebo treatment Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
All-Cause Mortality
Autologous Fibroblast Cheeks Placebo Cheeks Non-treatment Area Adverse Events
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Autologous Fibroblast Cheeks Placebo Cheeks Non-treatment Area Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/122 (0.00%)      0/122 (0.00%)      1/122 (0.82%)    
Injury, poisoning and procedural complications       
Intentional overdose * 1 [1]  0/122 (0.00%)  0 0/122 (0.00%)  0 1/122 (0.82%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Patient treated for overdose of recreational drugs after being biopsied and enrolled in the study, but prior to receiving any study treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Autologous Fibroblast Cheeks Placebo Cheeks Non-treatment Area Adverse Events
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/122 (9.02%)      10/122 (8.20%)      1/122 (0.82%)    
General disorders       
Swelling * 1 [1]  10/122 (8.20%)  29 10/122 (8.20%)  29 1/122 (0.82%)  1
Skin and subcutaneous tissue disorders       
Erythema * 1 [2]  11/122 (9.02%)  33 10/122 (8.20%)  29 1/122 (0.82%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Administration site conditions
[2]
Administration site condition
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publications or presentations by the Investigator or his associates, were required to be submitted to the sponsor for review and approval prior to publication or presentation in any form.
Results Point of Contact
Name/Title: Dr/ Joseph Fratantoni
Organization: Biologics Consulting Group
Phone: (301) 340-8432
Responsible Party: Fibrocell Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00642642     History of Changes
Other Study ID Numbers: IT-A-008
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: February 9, 2012
Results First Posted: August 21, 2013
Last Update Posted: August 21, 2013