Reduction of Hypertrophic Skin Scarring Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Within-subject, Placebo Controlled Study To Evaluate The Efficacy And Safety Of Pf 06473871 In Reducing Hypertrophic Skin Scarring
| Verified date | January 2016 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The study will compare how well PF-06473871 works versus placebo in reducing skin scarring after scar revision surgery of existing breast scars. The study will also evaluate the safety of PF-06473871 in healthy adult subjects.
| Status | Completed |
| Enrollment | 103 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Subjects must have hypertrophic (raised) breast scars from previous surgery - Subjects must be healthy Exclusion Criteria: - Currently pregnant or pregnant during the 6 months, prior to inclusion in the study or breast-feeding. - Presence of history of breast cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Noahklinik,Klinik Plastische, Rekonstruktive und Asthetische Chirurgie, Handchirurgie am Roten Kreuz | Kassel | Hessen |
| Hungary | Magyar Honvedseg-Egeszsegugyi Kozpont | Budapest | |
| Spain | Hospital Santa Creu I Sant Pau | Barcelona | |
| Spain | Clinica La Luz | Madrid | |
| United States | Advanced Medical Resarch ,Inc | Atlanta | Georgia |
| United States | Atlanta APC Plastic Surgery | Atlanta | Georgia |
| United States | Kavali Plastic Surgery and Skin Renewal Center | Atlanta | Georgia |
| United States | Perimeter Outpatient Surgery Center | Atlanta | Georgia |
| United States | Office of Paul M. Glat ,MD | Bala Cynwyd | Pennsylvania |
| United States | Sanctuary Mediacal Center | Boca Raton | Florida |
| United States | Northwestern University Diagnostic Testing Center | Chicago | Illinois |
| United States | Northwestern University,Division of Plastic Surgery | Chicago | Illinois |
| United States | Atlanta APC Plastic Surgery | Conyers | Georgia |
| United States | Stephan Baker, MD PA | Coral Gables | Florida |
| United States | Long Island Plastic Surgical Group, P.C | Garden City | New York |
| United States | The Hunstad Kortesis Center for Cosmetic Surgery | Huntersville | North Carolina |
| United States | University of California Irvine - Dermatology Research | Irvine | California |
| United States | Spivey Station Surgery Center | Jonesboro | Georgia |
| United States | Plastic Surgery and Laser Institute of San Diego | La Jolla | California |
| United States | Scripps Memorial-Ximed Medical Center | La Jolla | California |
| United States | Altus Research | Lake Worth | Florida |
| United States | Long Island Plastic Surgical Group, P.C. | Manhasset | New York |
| United States | Bayside Ambulatory Center | Miami | Florida |
| United States | Laser Skin Surgery Center of NY | New York | New York |
| United States | Virginia Clinical Research, Inc. | Norfolk | Virginia |
| United States | Black Hill Surgical Hospital | Rapid City | South Dakota |
| United States | Health Concepts | Rapid City | South Dakota |
| United States | Body Aesthetic Research Center | Saint Louis | Missouri |
| United States | Mercy Clinic Heart and Vascular | St. Louis | Missouri |
| United States | Fort Bend Imaging | Sugar Land | Texas |
| United States | Luxe Plastic Surgery | Sugar Land | Texas |
| United States | University of South Florida | Tampa | Florida |
| United States | Connall Consmetic Surgery | Tualatin | Oregon |
| United States | Meridian Center for Surgical Excellence, LLC | Tualatin | Oregon |
| United States | Timothy P. Connall, MD PC | Tualatin | Oregon |
| United States | Advanced Cosmetic Surgery Clinic of Walnut Creek | Walnut Creek | California |
| United States | Anthony DeMeo, MD | Walnut Creek | California |
| United States | Charles Hanson MD | Walnut Creek | California |
| United States | PIH health | Whittier | California |
| United States | PIH Health Plastic Surgery and Aesthetic Medicine | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Germany, Hungary, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight. | Baseline up to Week 24 | Yes |
| Other | Number of Participants With Abnormal Physical Examinations | Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems. | Baseline up to Week 24 | Yes |
| Other | Number of Participants With Electrocardiogram Findings | 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. | Baseline, Week 11 | Yes |
| Other | Number of Participants With Treatment Emergent Adverse Events (AEs) of Special Interest | Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea. | Baseline up to Week 24 | Yes |
| Other | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities | 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. | Baseline up to Week 24 | Yes |
| Primary | Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS) | 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. | Week 24 | No |
| Secondary | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) | 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. | Week 8, 11, 18, 24 | No |
| Secondary | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) | 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 | Week 8, 11, 18, 24 | No |
| Secondary | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score | 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. | Week 8, 24 | No |
| Secondary | Physician and Participant Photoguide Scar Assessment Scale Score | 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. | Week 8, 11, 18, 24 | No |