Trial Outcomes & Findings for Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring (NCT NCT00642642)

Last Updated: 2013-08-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

122 participants

Primary outcome timeframe

Baseline (prior to first treatment) and four months after last treatment

Results posted on

2013-08-21

Participant Flow

Patients were recruited between 7 Nov 2007 and 6 March 2008

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.

Participant milestones

Participant milestones
Measure	Autologous Fibroblasts and Placebo Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
Biopsy & Product Manufacture STARTED	122
Biopsy & Product Manufacture COMPLETED	109
Biopsy & Product Manufacture NOT COMPLETED	13
Treatment & Follow Up STARTED	109
Treatment & Follow Up COMPLETED	92
Treatment & Follow Up NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Autologous Fibroblasts and Placebo Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
Treatment & Follow Up Adverse Event	2
Treatment & Follow Up Withdrawal by Subject	5
Treatment & Follow Up Lost to Follow-up	10

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts and Placebo n=109 Participants Patients were treated with autologous fibroblasts on one cheek, and placebo on the opposite cheek
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	41.7 years STANDARD_DEVIATION 10.57 • n=93 Participants
Sex: Female, Male Female	62 Participants n=93 Participants
Sex: Female, Male Male	47 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants
Race (NIH/OMB) White	78 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline (prior to first treatment) and four months after last treatment

Population: 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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts Cheeks n=109 Participants Cheeks treated with autologous fibroblasts (azficel-T)	Placebo Cheeks n=109 Participants Cheeks treated with placebo solution
Evaluator Live Acne Scarring Assessment Responders	64 Participants	46 Participants

PRIMARY outcome

Timeframe: Baseline (prior to first treatment) and four months after last treatment

Population: Analysis was performed on the ITT population

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts Cheeks n=109 Participants Cheeks treated with autologous fibroblasts (azficel-T)	Placebo Cheeks n=109 Participants Cheeks treated with placebo solution
Subject Live Acne Scarring Assessment Responders	47 Cheeks	20 Cheeks

SECONDARY outcome

Timeframe: Baseline (prior to first treatment) compared to one, two, and three months after last treatment

Population: Number of cheeks for analysis was the ITT population

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts Cheeks n=109 Participants Cheeks treated with autologous fibroblasts (azficel-T)	Placebo Cheeks n=109 Participants Cheeks treated with placebo solution
Evaluator Live Acne Scarring Assessment Responders 1 Month Post Treatment	54 Participants	32 Participants
Evaluator Live Acne Scarring Assessment Responders 2 Months Post Treatment	56 Participants	41 Participants
Evaluator Live Acne Scarring Assessment Responders 3 Months Post Treatment	57 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline (prior to first treatment) compared to one, two, and three months after last treatment

Population: Analysis was performed on the ITT population

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts Cheeks n=109 Participants Cheeks treated with autologous fibroblasts (azficel-T)	Placebo Cheeks n=109 Participants Cheeks treated with placebo solution
Subject Live Acne Scarring Assessment Responders 1 Month Post Treatment	34 Cheeks	10 Cheeks
Subject Live Acne Scarring Assessment Responders 2 Months Post Treatment	41 Cheeks	15 Cheeks
Subject Live Acne Scarring Assessment Responders 3 Months Post Treatment	43 Cheeks	20 Cheeks

Adverse Events

Autologous Fibroblast Cheeks

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Cheeks

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Non-treatment Area Adverse Events

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Autologous Fibroblast Cheeks n=122 participants at risk Cheeks randomized to receive autologous fibroblast treatment	Placebo Cheeks n=122 participants at risk Cheeks randomized to receive placebo treatment	Non-treatment Area Adverse Events n=122 participants at risk Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/122 • 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).	0.00% 0/122 • 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).	0.82% 1/122 • Number of events 1 • 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

Other adverse events
Measure	Autologous Fibroblast Cheeks n=122 participants at risk Cheeks randomized to receive autologous fibroblast treatment	Placebo Cheeks n=122 participants at risk Cheeks randomized to receive placebo treatment	Non-treatment Area Adverse Events n=122 participants at risk Systemic adverse events and adverse events that occured outside of the study treatment area will be reported in this group
Skin and subcutaneous tissue disorders Erythema	9.0% 11/122 • Number of events 33 • 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).	8.2% 10/122 • Number of events 29 • 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).	0.82% 1/122 • Number of events 1 • 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).
General disorders Swelling	8.2% 10/122 • Number of events 29 • 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).	8.2% 10/122 • Number of events 29 • 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).	0.82% 1/122 • Number of events 1 • 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).

Additional Information

Dr/ Joseph Fratantoni

Biologics Consulting Group

Phone: (301) 340-8432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER