Safety and Efficacy Study of Different Dose Levels of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty

Pfizer30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Scar Prevention

Interventions

EXC 001DRUG

Intradermal injections of EXC 001 and placebo given on various schedules.

PlaceboDRUG

Intradermal injections of EXC 001 and placebo given on various schedules.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (2)

Northwestern University,Division of Plastic Surgery

Chicago, Illinois, United States

Body Aesthetic Plastic Surgery

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Part B: Expert Panel Scar Assessment Score

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.

Time frame: Week 13 of Part B

Secondary Outcomes

Part B: Physician Observer Global Assessment Scar Score

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.

Time frame: Week 13 of Part B

Part B: Number of Participants With Clinically Significant Change From Baseline in Vital Signs

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.

Time frame: Part B: Day 1 up to Week 14

Part B: Number of Participants With Clinically Significant Changes in Physical Examination Findings

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.

Data from ClinicalTrials.gov

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Part B: Number of Participants With Clinically Significant Abnormal Laboratory Findings

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.

Time frame: Part B: Day 1 up to Week 13