NCT01736969

Brief Summary

The purpose of this study is to determine whether a developmental formulation is substantially equivalent to the predicate device in the treatment of hypertrophic and keloid scars.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

7 months

First QC Date

October 12, 2012

Last Update Submit

November 30, 2012

Conditions

Hypertrophic ScarKeloid Scar

Outcome Measures

Primary Outcomes (1)

  • Comparison between groups in Vancouver Scar Scale total score from Baseline to Day 112 (or early termination)

    Vascularity, height/thickness, pliability, and pigmentation. Scoring from zero to thirteen.

    4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (3)

  • Pain and itch

    4 weeks, 8 weeks, 12 weeks

  • Adverse Events

    Baseline, Weeks: 2, 4, 8, 12 and early termination

  • Treatment satisfaction

    8 weeks, 12 weeks

Study Arms (2)

RD047-023

EXPERIMENTAL

RD-047-023

Device: RD047-023

Predicate Device

ACTIVE COMPARATOR

legally marketed predicate device

Device: Predicate Device

Interventions

RD047-023DEVICE

Experimental hydrogel

RD047-023
Predicate DeviceDEVICE
Also known as: Kelo-Cote
Predicate Device

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent and release health information
  • Ability to follow study instructions and study requirements
  • Have a hypertrophic or keloid scar accessible for treatment and evaluation
  • Negative pregnancy test for women of childbearing potential
  • Agreement to use effective birth control method for study duration

You may not qualify if:

  • History of allergy or sensitivity to components
  • History of diabetes
  • History of collagen vascular disorders
  • Anticipated need for surgery or hospitalization during the study
  • Pregnant, nursing, or planning a pregnancy during the study
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to Baseline (Day 0)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DermResearch Inc

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Cicatrix, HypertrophicKeloid

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janet C DuBois, MD

    Derm Research, PLLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2012

First Posted

November 29, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2013

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

US(1)