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| ID | Type | Description | Link |
|---|---|---|---|
| B5301004 | Other Identifier | Alias Study Number |
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The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator |
| |
| Group 2 | Placebo Comparator |
| |
| Group 3 | Placebo Comparator |
| |
| Group 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXC 001 | Drug | Single-dose administered by injection four different times |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Observer Scar Assessment Score at Week 24 | Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Observer Scar Assessment Score | Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated 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, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Deep Laser Medical Spa | Pasadena | California | 91105 | United States | ||
| Bright Health Physicans Plastic Surgery and Aesthetic Medicine |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants who previously had breast surgery resulting in unacceptable bilateral scars and had chosen to have the breast scars revised were recruited in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXC 001 (PF-06473871) 5 mg/cm | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 milligram per linear centimeter (mg/cm) at Week 2, 5, 8 and 11 to a 5 centimeter (cm) section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| EXC 001 |
| Drug |
Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1 |
|
| EXC 001 | Drug | Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2 |
|
| EXC 001 | Drug | Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3 |
|
| Week 11, 18 |
| 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 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair. | Week 11, 18, 24 |
| Subject Observer Scar Assessment Score | 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 = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome. | Week 24 |
| Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 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 participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). | Week 24 |
| Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 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 participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). | Week 24 |
| Whittier |
| California |
| 90602 |
| United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Bayside Ambulatory Center | Miami | Florida | 33133 | United States |
| Aesthetic Plastic Surgery Miami | Miami | Florida | 33146 | United States |
| Body Aesthetic Plastic Surgery | St Louis | Missouri | 63141 | United States |
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| Mark L. Jewell,MD Surgery Center | Eugene | Oregon | 97401 | United States |
| Connall Consmetic Surgery | Tualatin | Oregon | 97062 | United States |
| Endeavor Clinical Trials,P.A. | San Antonio | Texas | 78229 | United States |
| Texas Plastic Surgery | San Antonio | Texas | 78240-1670 | United States |
| BAXTER Plastic Surgery | Mountlake Terrace | Washington | 98043 | United States |
| FG001 | EXC 001 (PF-06473871) 2 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| FG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| FG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis population was defined as all participants that have missed no more than 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EXC 001 (PF-06473871) 5 mg/cm | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast. |
| BG001 | EXC 001 (PF-06473871) 2 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| BG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| BG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Observer Scar Assessment Score at Week 24 | Physician assessment of scar was done using a valid published 10-point rating scale. Physician rated vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion for scar on a score of 1 = normal skin to 10 = worst scar imaginable, where lower scores indicated better outcome. Composite score was the sum of all the scores, except the overall opinion score, and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Physician Observer Scar Assessment Score | Physician observer scar assessment score was done using a valid published 10-point rating scale. Physician rated 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, where lower scores indicated better outcome. Composite score was the sum of all the scores except the overall opinion score and range from 6 (best score) to 60 (worst score), where lower scores indicated better outcome. Within participant treatment difference was assessed between the treatment regimens each participant received. | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 11, 18 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 = best possible scar and a score of 100 = worst possible scar, where lower scores indicated better outcome. The rater first marked a rating for the "worse" scar and then rated the other scar. The difference between these two ratings was the "improvement of scar severity." If there was no difference, the expert could check a box to indicate that determination. This method provided information on the absolute severity of the scars as well as the differences between the two scars in the pair. | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time point for each group, respectively. | Posted | Mean | Standard Deviation | units on a scale | Week 11, 18, 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subject Observer Scar Assessment Score | 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 = sum of all scores except overall opinion and range 6 (best) to 60 (worst). Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst). Within participant treatment difference was assessed between the treatment regimens each participant received. A lower score indicated a better outcome. | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (Overall Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Physician Photonumeric Guide Scar Assessment Score | 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 participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Participant Photonumeric Guide Scar Assessment Score | 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 participants with different ratings of scar severity were reported. Same participant was reported twice, once for each breast's scar (dosing for 1 breast = 4 times EXC 001 and for other breast = 3 times). | Analysis population included all participants who missed not more than 1 dose of study drug, had physician observer scar assessment score at all specified time-points. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | Week 24 |
|
Day 1 up to Week 24
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EXC 001 (PF-06473871) 5 mg/cm | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 3 intradermal injections of EXC 001 at dose of 5 mg/cm at Week 2, 5, 8 and then 1 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 11 to 5 cm section of both sides of the revised scar on another breast. | 0 | 27 | 13 | 27 | ||
| EG001 | EXC 001 (PF-06473871) 2 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 0 | 14 | 2 | 14 | ||
| EG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 0 | 13 | 2 | 13 | ||
| EG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. | 0 | 13 | 3 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Application site rash | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Scar pain | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Procedural site reaction | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Breast induration | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Vascularity |
|
| Pigmentation |
|
| Thickness |
|
| Relief |
|
| Pliability |
|
| Surface Area |
|
| Composite Score |
|
|
Vascularity: Intraparticipant analysis |
| Mixed Models Analysis |
| 1.000 |
| LS Mean |
| 0.0 |
| Standard Error of the Mean |
| 0.37 |
| 2-Sided |
| 95 |
| -0.7 |
| 0.7 |
| Other |
LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pigmentation: Intraparticipant analysis | Mixed Models Analysis | 0.391 | LS Mean | -0.3 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | -1.0 | 0.4 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Thickness: Intraparticipant analysis | Mixed Models Analysis | 0.696 | LS Mean | 0.2 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -0.6 | 0.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Relief: Intraparticipant analysis | Mixed Models Analysis | 0.921 | LS Mean | 0.0 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -0.7 | 0.8 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pliability: Intraparticipant analysis | Mixed Models Analysis | 0.693 | LS Mean | 0.2 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -0.6 | 0.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Surface Area: Intraparticipant analysis | Mixed Models Analysis | 0.770 | LS Mean | 0.1 | Standard Error of the Mean | 0.39 | 2-Sided | 95 | -0.7 | 0.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Composite Score: Intraparticipant analysis | Mixed Models Analysis | 0.938 | LS Mean | 0.2 | Standard Error of the Mean | 1.98 | 2-Sided | 95 | -3.7 | 4.0 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Overall Opinion: Intraparticipant analysis | Mixed Models Analysis | 0.340 | LS Mean | -0.5 | Standard Error of the Mean | 0.52 | 2-Sided | 95 | -1.5 | 0.5 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Vascularity: Intraparticipant analysis | Mixed Models Analysis | 0.258 | LS Mean | -0.6 | Standard Error of the Mean | 0.50 | 2-Sided | 95 | -1.6 | 0.4 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pigmentation: Intraparticipant analysis | Mixed Models Analysis | 0.381 | LS Mean | -0.4 | Standard Error of the Mean | 0.49 | 2-Sided | 95 | -1.4 | 0.5 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Thickness: Intraparticipant analysis | Mixed Models Analysis | 0.287 | LS Mean | -0.6 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.6 | 0.5 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Relief: Intraparticipant analysis | Mixed Models Analysis | 0.420 | LS Mean | -0.4 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.5 | 0.6 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pliability: Intraparticipant analysis | Mixed Models Analysis | 0.227 | LS Mean | -0.6 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.7 | 0.4 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Surface Area: Intraparticipant analysis | Mixed Models Analysis | 0.427 | LS Mean | -0.4 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.5 | 0.6 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Composite Score: Intraparticipant analysis | Mixed Models Analysis | 0.256 | LS Mean | -3.1 | Standard Error of the Mean | 2.70 | 2-Sided | 95 | -8.4 | 2.2 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Overall Opinion: Intraparticipant analysis | Mixed Models Analysis | 0.198 | LS Mean | 0.8 | Standard Error of the Mean | 0.62 | 2-Sided | 95 | -0.4 | 2.0 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Vascularity: Intraparticipant analysis | Mixed Models Analysis | 0.132 | LS Mean | 0.9 | Standard Error of the Mean | 0.60 | 2-Sided | 95 | -0.3 | 2.1 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pigmentation: Intraparticipant analysis | Mixed Models Analysis | 0.227 | LS Mean | 0.7 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -0.4 | 1.8 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Thickness: Intraparticipant analysis | Mixed Models Analysis | 0.208 | LS Mean | 0.8 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -0.4 | 2.0 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Relief: Intraparticipant analysis | Mixed Models Analysis | 0.265 | LS Mean | 0.7 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -0.5 | 1.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pliability: Intraparticipant analysis | Mixed Models Analysis | 0.340 | LS Mean | 0.6 | Standard Error of the Mean | 0.63 | 2-Sided | 95 | -0.6 | 1.8 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Surface Area: Intraparticipant analysis | Mixed Models Analysis | 0.347 | LS Mean | 0.6 | Standard Error of the Mean | 0.64 | 2-Sided | 95 | -0.7 | 1.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Composite Score: Intraparticipant analysis | Mixed Models Analysis | 0.179 | LS Mean | 4.3 | Standard Error of the Mean | 3.19 | 2-Sided | 95 | -2.0 | 10.6 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Overall Opinion: Intraparticipant analysis | Mixed Models Analysis | 0.556 | Least Square (LS) Mean | -0.3 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.4 | 0.8 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Vascularity: Intraparticipant analysis | Mixed Models Analysis | 0.760 | LS Mean | -0.2 | Standard Error of the Mean | 0.54 | 2-Sided | 95 | -1.2 | 0.9 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pigmentation: Intraparticipant analysis | Mixed Models Analysis | 0.636 | LS Mean | -0.3 | Standard Error of the Mean | 0.53 | 2-Sided | 95 | -1.3 | 0.8 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Thickness: Intraparticipant analysis | Mixed Models Analysis | 0.774 | LS Mean | -0.2 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.3 | 1.0 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Relief: Intraparticipant analysis | Mixed Models Analysis | 0.771 | LS Mean | -0.2 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.3 | 1.0 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Pliability: Intraparticipant analysis | Mixed Models Analysis | 0.468 | LS Mean | -0.4 | Standard Error of the Mean | 0.57 | 2-Sided | 95 | -1.5 | 0.7 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Surface Area: Intraparticipant analysis | Mixed Models Analysis | 0.886 | LS Mean | -0.1 | Standard Error of the Mean | 0.58 | 2-Sided | 95 | -1.2 | 1.1 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
| Composite Score: Intraparticipant analysis | Mixed Models Analysis | 0.668 | LS Mean | -1.3 | Standard Error of the Mean | 2.91 | 2-Sided | 95 | -7.0 | 4.5 | Other | LS Mean, SE, 95% confidence interval, and p-value were derived from MMRM model that includes fixed factors for treatment, pooled site, scheduled visit, an interaction for treatment by scheduled visit, and a covariate for Fitzpatrick category. |
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
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|
| EXC 001 (PF-06473871) 2 mg/cm and Placebo |
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
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|
| OG001 |
| EXC 001 (PF-06473871) 2 mg/cm and Placebo |
Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 2 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
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|
| OG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
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|
| OG002 | EXC 001 (PF-06473871) 0.8 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 0.8 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
| OG003 | EXC 001 (PF-06473871) 5 mg/cm and Placebo | Participants received 4 intradermal injections of EXC 001 (PF- 06473871) at dose of 5 mg/cm at Week 2, 5, 8 and 11 to a 5 cm section of both sides of the revised scar on 1 breast and 4 intradermal injections of placebo matched to EXC 001 (PF- 06473871) at Week 2, 5, 8 and 11 to 5 cm section of both sides of the revised scar on another breast. |
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