Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery

Scar Prevention Clinical Trial

Official title:

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT CONTROLLED STUDY TO EVALUATE EFFICACY AND SAFETY OF EXC 001 FOR THE AMELIORATION OF SCARRING FOLLOWING REVISION OF SCARS RESULTING FROM PRIOR BREAST SURGERY IN ADULT FEMALE SUBJECTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037413
• Other study ID #: EXC 001-203
• Secondary ID: B5301011
• Status: Completed
• Phase: Phase 2
• Start date: December 22, 2009
• Est. completion date: April 9, 2010

Study information

• Verified date: June 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare how well EXC 001 works to improve the appearance of scars in subjects undergoing breast scar revision surgery. The study will also evaluate the safety of EXC 001 in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 9, 2010
• Est. primary completion date: April 9, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subjects must have previously had breast surgery resulting in unacceptable scars
• Subject has chosen to have the breast scars revised
• Subjects must not be pregnant or lactating

Exclusion Criteria:

• Currently pregnant or pregnant during the 6 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

Related Conditions & MeSH terms

• Scar Prevention

Intervention

Drug:
• EXC 001
Multiple intradermal injections of EXC 001 and placebo
• Placebo
Multiple intradermal injections of EXC 001 and placebo

Locations

Country	Name	City	State
United States	Northwestern University,Division of Plastic Surgery	Chicago	Illinois
United States	Jewell Plastic Surgery Center	Eugene	Oregon
United States	Scripps medical	La Jolla	California
United States	Body Aesthetic Plastic Surgery	Saint Louis	Missouri
United States	Connall Consmetic Surgery	Tualatin	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expert Panel Scar Assessment Score at Week 12	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.	Part B: Week 12
Secondary	Expert Panel Scar Assessment Score at Week 8 and 24	Scar assessment by an expert panel was done on blinded photographs using 100 mm 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.	Part B: Week 8 and 24
Secondary	Physician Observer Scar Assessment Score at Week 12 and 24	Physician observer 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 a scar on a score of 1= normal skin to 10= worst scar imaginable, where higher scores indicate worse condition. 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 higher scores indicate worse condition.	Part B: Week 12 and 24
Secondary	Participant Observer Scar Assessment Score at Week 12 and 24	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), where higher scores indicate worse condition. Composite score = sum of all scores except overall opinion, range 6 (best) to 60 (worst), where higher scores indicate worse condition. Scar appearance composite score = sum of all scores except overall opinion, pain and itching, range 4 (best) to 40 (worst), where higher scores indicate worse condition.	Part B: Week 12 and 24
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs and all non-SAEs that occurred during the study.	Part A: Day 1; Part B, Active Dosing: Week 2 up to Week 13; Part B, Post Dosing: Week 13 to end of the study (Week 24)
Secondary	Number of Participants With Abnormal 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. Abnormal physical examination findings was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1, Week 12
Secondary	Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG)	Number of participants with clinically significant abnormality in ECG were reported. Clinical significance was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Week 12
Secondary	Number of Participants With Clinically Significant Findings in Laboratory Examinations	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 findings were reported.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Secondary	Number of Participants With Clinically Significant Findings in Vital Signs	Following vital sign parameters were assessed: diastolic blood pressure, systolic blood pressure, respiration rate, pulse rate, and temperature. Clinical significance was based on investigator's discretion.	Screening (up to Day 21 prior to Day 1 of Part A), Part B: Day 1 up to Week 12
Secondary	Number of Participants With Positive Skin Sensitivity Reaction	Participants were instructed to inform the investigator in case of any itching, redness, pain or any other symptom that appears to be a rash at the injection sites. Erythematous, raised (indurated) and edematous reactions were considered as positive skin sensitivity reactions.	Part A: Day 1, Part B: Week 2 up to Week 24

External Links

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