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

NCT01038297 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: EXC 001-201B5301009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Scar Prevention

Keywords

Scarring

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 13 of Part B

Secondary Outcomes (6)

• Part B: Physician Observer Global Assessment Scar Score

  Week 13 of Part B

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

  Part B: Day 1 up to Week 14

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

  Part B: Day 1 up to Week 14

• Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings

  Week 13 of Part B

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

  Part B: Day 1 up to Week 13

Study Arms (2)

EXC 001

EXPERIMENTAL

Drug: EXC 001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

EXC 001 DRUG

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

EXC 001

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Subjects with existing scars or significant striae on the abdominal pannus
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Northwestern University,Division of Plastic Surgery

Chicago, Illinois, 60611, United States

Location

Body Aesthetic Plastic Surgery

St Louis, Missouri, 63141, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2009
• Primary Completion: July 7, 2010
• Study Completion: July 7, 2010
• Last Updated: September 20, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)