Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
- Registration Number
- NCT01038297
- Lead Sponsor
- Pfizer
- Brief Summary
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty
- Subject has chosen to have an elective abdominoplasty
- Medically healthy with normal screening results
- Subjects must not be pregnant or lactating
- Subjects with existing scars or significant striae on the abdominal pannus
- Females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating
- Participation in another clinical trial within 30 days prior to the start of the study
- Any other condition or prior therapy, which, in the opinion of the PI, would make the subject unsuitable for this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXC 001 EXC 001 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Part B: Expert Panel Scar Assessment Score Week 13 of Part B Scar assessment by an expert panel was done on blinded photographs using 100 millimeter (mm) visual analog scale (VAS) where a score of 0 mm = best possible scar and a score of 100 mm = worst possible scar, where higher scores indicate worse condition. The difference was calculated for scars at Week 13 as EXC 001 score minus placebo score, thus a negative difference would indicate that the EXC 001-treated scars had lower scar severity. The score was defined as the within participant average difference between EXC 001- and Placebo-treated scars at Week 13.
- Secondary Outcome Measures
Name Time Method Part B: Physician Observer Global Assessment Scar Score Week 13 of Part B Physician observer global assessment of scar score was done using a valid published 10-point rating scale. Physicians rated severity of each scar on a scale of 1 = normal skin to 10 = worst scar imaginable. Each scar was given a single score and the differences in scores between the matched pairs of scars were calculated. There were 4 differences within each dose level that were averaged to create a single score for each participant at each dose level. The score was defined as the within participant average difference between EXC 001 and Placebo.
Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Part B: Day 1 up to Week 14 Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, temperature and weight. Number of participants with clinically significant change in any vital sign parameter compared to Baseline were reported. Criteria for clinically significant change in any vital sign parameter compared to baseline was based on investigator's discretion.
Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings Part B: Day 1 up to Week 14 Physical examination included the assessment of skin; head, ears, eyes, nose, and throat; respiratory; cardiovascular; abdomen; musculoskeletal; neurological; gastrointestinal; genitourinary; endocrine and lymph nodes. Criteria for clinically significant findings in physical examination was based on investigator's discretion.
Part A and B: Number of Participants With Positive Skin Sensitivity Reaction From Day 21 of Part A up to Week 2 of Part B The skin sensitivity reaction was assessed only at the skin sensitivity reaction testing sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions. The number of participants that experienced any positive skin sensitivity reactions were reported.
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings Week 13 of Part B Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's correction (QTc), heart rate (HR). A standard, single 12-lead ECG was taken and results was classified as normal, having a clinically insignificant abnormality, or having a clinically significant abnormality. Number of participants with clinically significant abnormality in ECG compared to baseline were reported. Criteria for clinically significant abnormality in ECG compared to baseline was based on investigator's discretion.
Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings Part B: Day 1 up to Week 13 Laboratory analysis included hematology, biochemistry and urinalysis. Hematology range: basophils (bas) 0-0.2, eosinophils (eos) 0-0.4, leukocytes (leu) 4-10.5, lymphocytes (lym) 0.7-4.5, neutrophils (neu) 1.8-7.8, platelet 140-415, monocytes (mon) 0.1-1 in 10\^9 per liter; bas/leu 0-3, eos/leu 0-7, lym/leu 14-46, mon/leu 4-13, neu/leu and neu/leu 40-74 in percentage, erythrocytes 3.8-5.1 10\^12/L, hematocrit 0.34-0.44 L/L, hemoglobin 115-150 gram per liter (g/L). Biochemistry range: creatine kinase 24-173, alkaline phosphatase 25-150, alanine aminotransferase (AT) and aspartate AT 0-40 in International units per liter; creatinine 50-88, urate 89-399, bilirubin 2-21 in micromole per liter, glucose 3.6-5.5, potassium 3.5-5.5, sodium 135-148, blood urea nitrogen 1.8-9.3 in millimole/L, albumin 35-55 g/L. Urinalysis parameters: pH (5-7.5), specific gravity (1.005-1.03). Participants with clinically significant abnormal change in any laboratory parameter compared to baseline were reported.
Trial Locations
- Locations (2)
Northwestern University,Division of Plastic Surgery
🇺🇸Chicago, Illinois, United States
Body Aesthetic Plastic Surgery
🇺🇸Saint Louis, Missouri, United States