Trial Outcomes & Findings for Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases (NCT NCT00654654)

Last Updated: 2012-03-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

50 participants

Primary outcome timeframe

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

Results posted on

2012-03-13

Participant Flow

Patients were recruited between 22 March 2007 and 8 August 2007

Participant milestones

Participant milestones
Measure	Autologous Fibroblasts Patients received treatment with autologous fibroblasts to multiple facial regions
Overall Study STARTED	50
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous Fibroblasts n=50 Participants Patients received treatment with autologous fibroblasts to multiple facial regions
Age Continuous	47.4 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized White participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Non-white participants	2 Participants n=5 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=41 Participants Patients treated with autologous human fibroblasts
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = -1 (worse)	2 participants
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = 0 (no change)	5 participants
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = +1 (better)	15 participants
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = +2 (better)	11 participants
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = +3 (better)	7 participants
Change in Subject Assessment of Wrinkles Compared to Baseline on Subject Wrinkle Assessment Change = +4 (better)	1 participants

PRIMARY outcome

Timeframe: Baseline (prior to treatment) compared to 6 months post last treatment

Population: Number of patients for whom data were available

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.

Outcome measures

Outcome measures
Measure	Autologous Fibroblasts n=44 Participants Patients treated with autologous human fibroblasts
Independent Panel Global Improvement Assessment Compared to Baseline No improvement	10 participants
Independent Panel Global Improvement Assessment Compared to Baseline Mild improvement	29 participants
Independent Panel Global Improvement Assessment Compared to Baseline Moderate improvement	5 participants
Independent Panel Global Improvement Assessment Compared to Baseline Marked improvement	0 participants

Adverse Events

Active

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=50 participants at risk Patients treated with autologous human fibroblasts
Metabolism and nutrition disorders Dehydration	2.0% 1/50 • Number of events 1 • Adverse event data were collected for six months after final study treatment
Psychiatric disorders Alcoholism	2.0% 1/50 • Number of events 1 • Adverse event data were collected for six months after final study treatment
Musculoskeletal and connective tissue disorders Back Pain	2.0% 1/50 • Number of events 1 • Adverse event data were collected for six months after final study treatment

Other adverse events

Other adverse events
Measure	Active n=50 participants at risk Patients treated with autologous human fibroblasts
Skin and subcutaneous tissue disorders Acne	8.0% 4/50 • Adverse event data were collected for six months after final study treatment
Nervous system disorders Headache	6.0% 3/50 • Adverse event data were collected for six months after final study treatment
General disorders Injection site bruising	10.0% 5/50 • Adverse event data were collected for six months after final study treatment
General disorders Injection site erythema	12.0% 6/50 • Adverse event data were collected for six months after final study treatment
General disorders Injection site nodule	8.0% 4/50 • Adverse event data were collected for six months after final study treatment
General disorders Injection site pain	6.0% 3/50 • Adverse event data were collected for six months after final study treatment
General disorders Injection site swelling	10.0% 5/50 • Adverse event data were collected for six months after final study treatment
Infections and infestations Nasophayngitis	6.0% 3/50 • Adverse event data were collected for six months after final study treatment
Infections and infestations Urinary tract infection	6.0% 3/50 • Adverse event data were collected for six months after final study treatment

Additional Information

Kevin Hennegan

CBR International Corp.

Phone: (720)746-1190

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