Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001

A PHASE 2, OPEN-LABEL STUDY TO PROVIDE REVISION OF SCARS RESULTING FROM SURGERY IN PRIOR STUDIES OF EXC 001

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01494922

Enrollment

Registered

2011-12-19

Start date

2011-12-08

Completion date

2013-09-10

Last updated

2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reduction in Severity of Skin Scarring

Keywords

Skin scarring, cicatrix, hypertrophic scar, hypertrophic scar prevention

Brief summary

The purpose of this study is to provide subjects who participated in prior studies of EXC 001 the opportunity to have their hypertrophic scars surgically revised and treated with EXC 001.

Interventions

DRUGEXC 001 (currently called PF-06473871)

Single dose administered by injection at four different times

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Healthy adults who have participated in previous studies of EXC 001. * Healthy adults who have chosen to have their scars revised.

Exclusion criteria

* Currently pregnant or pregnant during the 6 months prior to inclusion in the study, or breast feeding. * Participation in another clinical trial within 30 days prior to the start of the study.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Abnormalities in Physical Examinations	Day 1 up to Week 24	Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion.
Number of Participants With Positive Skin Sensitivity Reaction	Day 1 up to Week 24	Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appeared to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. In this outcome measure number of participants with any positive skin sensitivity reaction were reported.
Number of Participants With Clinically Significant Findings in Laboratory Examinations	Day 1 up to Week 24	Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Hepatobiliary biochemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin ; Renal Function Tests: Blood Urea Nitrogen (BUN), Creatinine, Creatinine Kinase, Uric Acid ; Electrolytes: Sodium, Potassium; Glucose; Urine analysis: (decimal logarithm of reciprocal of hydrogen ion activity )\[pH\], Specific gravity. Clinically significant laboratory abnormality findings were based on investigator discretion.
Number of Participants With Clinically Significant Change in Vital Signs	Day 1 up to Week 24	Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and body weight. Number of participants with clinically significant change in any vital sign parameter compared to baseline were reported. Clinically significant change in vital signs criteria were based on investigator's discretion.
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities	Day 1 up to Week 24	Following parameters were analyzed: heart rate, PR interval, QT interval, QRS interval and QT interval corrected using Fridericia's formula (QTcF). Clinically significant findings in ECG were based on investigator's discretion.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Week 2 to Week 24	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study.

Secondary

Measure	Time frame	Description
Participant Observer Scar Assessment Score: Individual Sub Scores, Composite Score, Scar Appearance Composite Score	Week 24	Participants rated pain, itching, color, stiffness, thickness, irregularity and overall opinion of scar on 10-point scale. For pain and itching associated with scar: range = 1 (no, not at all) to 10 (yes, worst imaginable) and for other parameters associated with scar compared to normal skin: range = 1 (no, same as normal skin) to 10 (yes, very different). Composite score is the sum of all sub scores except overall opinion, range 6 (best) to 60 (worst). Scar appearance composite score is the sum of all sub scores except overall opinion, pain and itching, range 4 (best) to 40 (worst).
Number of Scars Classified According to Physician Photonumeric Guide Score Severity Category	Week 24	Physician rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants.
Number of Scars Classified According to Subject Participant Photonumeric Guide Score Severity Category	Week 24	Participants rated severity of each scar using a photonumeric guide on a scale range from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Number of scars with different ratings of scar severity were reported. Participants may have received treatment for multiple scars (up to 5 scars), results are reported for all scars (individual scar) and most severe scar for all the participants.
Physician Observer Scar Assessment Score: Individual Sub Scores and Composite Score	Week 24	Physician assessment of scar was done using a valid published 10-point rating scale. Assessment included following sub scores: vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar, on a score of 1 = normal skin to 10 = worst scar imaginable. Composite score was the sum of all the sub scores except the overall opinion score and range from 6 (best score) to 60 (worst score).

Countries

United States

Participant flow

Recruitment details

Participants who participated in any of the previous studies (EXC 001-202 \[NCT01037985\], EXC 001-203 \[NCT01037413\] and EXC 001-204 \[NCT01346969\]), had scars at a minimum of 1 year after surgery in previous study which qualified for scar revision and chose scar revision treatment with EXC 001 (PF-06473871) were eligible for this study.

Participants by arm

Arm	Count
EXC 001 (PF-06473871) Participants who underwent scar revision surgery on Day 1 and received 4 intradermal injections of EXC 001 (PF-06473871) at a dose of 5 mg/cm at Week 2, 5, 8 and 11 after the surgical incision was closed, to both sides of the incision/scar. Participants received treatment for total scar length of up to 14 cm.	14
Total	14

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1

Baseline characteristics

Characteristic	EXC 001 (PF-06473871)
Age, Continuous	44.0 years STANDARD_DEVIATION 7.51
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	8 / 14
serious Total, serious adverse events	0 / 14

Outcome results

Primary

Number of Participants With Abnormalities in Physical Examinations

Physical examination included the assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, abdomen (including liver and kidneys), musculoskeletal system, neurological system, gastrointestinal system, genitourinary system, endocrine system and lymph nodes. Abnormality in physical examination were based on investigator's discretion.

Time frame: Day 1 up to Week 24