Safety and Efficacy Study of PF-06473871 to Reduce Hypertrophic Scars From Recurring Post-Revision Surgery

Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the participant's scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within participant treatment difference was assessed between the treatment regimens each participant received.

Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within participant treatment difference was assessed between the treatment regimens each participant received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1.

Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within participant treatment difference was assessed between the treatment regimens each participant received

PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Participants completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0-100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Within participant treatment difference was assessed between the treatment regimens each participant received.

Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within participant treatment difference was assessed between the treatment regimens each participant received.

Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight.

Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems.

Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator.

Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported.