Trial Outcomes & Findings for A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids (NCT NCT00587587)
NCT ID: NCT00587587
Last Updated: 2011-08-19
Results Overview
Summary of all reported adverse events (AE) in the intent to treat (ITT) population. AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
COMPLETED
PHASE1/PHASE2
30 participants
52 weeks
2011-08-19
Participant Flow
Participant milestones
| Measure |
Apligraf
Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Control
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
13
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Apligraf
Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Control
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
Baseline Characteristics
A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised Keloids
Baseline characteristics by cohort
| Measure |
Apligraf
n=17 Participants
Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Control
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
32.7 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
34.4 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: ITT analysis per protocol. Report of at least 1 treatment emergent AE.
Summary of all reported adverse events (AE) in the intent to treat (ITT) population. AE was defined as any adverse change in the subject's medical status compared with the subject's baseline condition, whether or not the event was related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition. AE data were collected at every study visit or if volunteered by the subject at any time during the study.
Outcome measures
| Measure |
A (Apligraf)
n=17 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Any AE
|
12 Participants
|
10 Participants
|
|
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
|
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Unanticipated Adverse Device Effect (UADE)
|
0 Participants
|
0 Participants
|
|
The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.
Deaths
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52 or Last VisitPopulation: Modified ITT (mITT) for randomized subjects only. Last Visit is the score recorded at last subject visit with non-missing data.
Change in BSS cumulative score, Baseline to Last Visit, as reported by the Investigator, is reported. BSS is a composite score where the individual scores from the following categories are summed: Color (rated 1\[perfect\]-4\[gross mismatch\]), Shine (1/Matte or 2/Shiny), Contour (rated 1\[flush with surrounding skin\]-4\[keloid\]), Distortion (rated 1\[None\]-4\[severe\]), Texture (rated 1\[normal\]-4\[hard\]), and Overall Assessment on a 10cm visual analog scale (rated 0\[excellent scar\]-10 \[poor scar\]). Total score ranges from 5 (clinically well healed scar) - 28 (clinically poor scar).
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Change in Degree of Keloid Recurrence as Measured by Beausang Scar Scale (BSS)
|
-8.8 Units on a scale
Standard Deviation 5.1
|
-9.7 Units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Cumulative assessment, mITT population for randomized subjects only
Recurrence is defined the first study visit at which the Investigator scores the Contour component of the BSS with a 4 (indicating a keloid). Contour is one of the five components measured in the BSS with Contour scores ranging from 1 (flush with surrounding skin) to 4 (keloid). Recurrence is a negative outcome.
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Cumulative Incidence of Keloid Recurrence at Week 52
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 52 or Last VisitPopulation: mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.
Scar firmness measured by Cutometer in millimeters.
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Degree of Recurrence (Scar Firmness)
|
0.2 mm
Standard Deviation 0.1
|
0.2 mm
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Week 52 or Last visitPopulation: mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.
Scar thickness measured by slide caliper in millimeters. A value of 0.0 mm on the slide caliper is equivalent to normal, non-hypertrophic/raised skin.
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Degree of Recurrence (Scar Thickness)
|
2.0 mm
Standard Deviation 2.2
|
1.0 mm
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 52 or Last VisitPopulation: mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.
Investigator assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Physician Global Assessment
Excellent
|
3 Participants
|
3 Participants
|
|
Physician Global Assessment
Very Good
|
3 Participants
|
3 Participants
|
|
Physician Global Assessment
Good
|
0 Participants
|
2 Participants
|
|
Physician Global Assessment
Moderate
|
5 Participants
|
4 Participants
|
|
Physician Global Assessment
Poor
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 52 or Last VisitPopulation: mITT population (randomized subjects only). Last Visit is the score recorded at last subject visit with non-missing data.
Subject assessed using 5 point scale (1-excellent, 2-very good, 3-good, 4-moderate, 5-poor)
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Subject Global Assessment
Excellent
|
4 Participants
|
6 Participants
|
|
Subject Global Assessment
Very Good
|
1 Participants
|
3 Participants
|
|
Subject Global Assessment
Good
|
5 Participants
|
2 Participants
|
|
Subject Global Assessment
Moderate
|
2 Participants
|
1 Participants
|
|
Subject Global Assessment
Poor
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: mITT population (randomized subjects only)
The mean number of Intralesional (IL) Injections per participant is reported. A lower number of injections is a better outcome.
Outcome measures
| Measure |
A (Apligraf)
n=12 Participants
Apligraf (bilayered living cell therapy)
|
B (Control)
n=13 Participants
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Decreased Utilization of Intralesional Steroid Intervention
|
4.0 Injections per Participant
Standard Deviation 1.8
|
4.2 Injections per Participant
Standard Deviation 1.0
|
Adverse Events
Apligraf
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apligraf
n=17 participants at risk
Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
Control
n=13 participants at risk
Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Gastroenteritis Viral
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2
|
0.00%
0/13
|
|
General disorders
Inflammation
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Tinea Versicolour
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Wound Infection
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Infections and infestations
Wound Infection Bacterial
|
0.00%
0/17
|
7.7%
1/13 • Number of events 2
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/17
|
7.7%
1/13 • Number of events 2
|
|
Injury, poisoning and procedural complications
Wound Complication
|
29.4%
5/17 • Number of events 8
|
53.8%
7/13 • Number of events 9
|
|
Injury, poisoning and procedural complications
Wound Haemorrhage
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Headache
|
17.6%
3/17 • Number of events 3
|
0.00%
0/13
|
|
Pregnancy, puerperium and perinatal conditions
Vomiting in Pregnancy
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
5.9%
1/17 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
17.6%
3/17 • Number of events 3
|
30.8%
4/13 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/17
|
7.7%
1/13 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60