Safety and Efficacy of EXC 001 in Subjects Who Have Participated in Prior Studies of EXC 001
- Conditions
- Reduction in Severity of Skin Scarring
- Interventions
- Drug: EXC 001 (currently called PF-06473871)
- Registration Number
- NCT01494922
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Healthy adults who have participated in previous studies of EXC 001.
- Healthy adults who have chosen to have their scars revised.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Open Label EXC 001 (currently called PF-06473871) -
- Primary Outcome Measures
Name Time Method 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.
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 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 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 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.
- Secondary Outcome Measures
Name Time Method 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).
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.
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).
Trial Locations
- Locations (4)
Altus Research
🇺🇸Lake Worth, Florida, United States
Northwestern University,Division of Plastic Surgery
🇺🇸Chicago, Illinois, United States
Connall Consmetic Surgery
🇺🇸Tualatin, Oregon, United States
Jewell Plastic Surgery Center
🇺🇸Eugene, Oregon, United States