ClinicalTrials.Veeva

Menu

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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 2

Conditions

Scar Prevention

Treatments

Drug: Placebo
Drug: EXC 001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01038297
EXC 001-201
B5301009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • Subjects with existing scars or significant striae on the abdominal pannus
  • Females who are currently pregnant or pregnant during the 12 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups, including a placebo group

EXC 001
Experimental group
Treatment:
Drug: EXC 001
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems