NCT01409863

Brief Summary

The goals of this study will be to compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2010

Status
withdrawn

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

March 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

Same day

First QC Date

August 2, 2011

Last Update Submit

October 2, 2023

Conditions

Scar

Keywords

post surgical or post traumatic scar on face or scalp

Outcome Measures

Primary Outcomes (1)

  • safety and efficacy of fractional photothermolysis

    compare the safety and efficacy of fractional photothermolysis (Fraxel) with dermabrasion when used for scar revision.

    Post Surgery

Study Arms (1)

laser and standard diamond fraise dermabrasion

NO INTERVENTION

laser and standard diamond fraise dermabrasion

Procedure: laser and standard diamond fraise dermabrasion

Interventions

laser and standard diamond fraise dermabrasionPROCEDURE

standard dermabrasion, CO2 laser resurfacing

laser and standard diamond fraise dermabrasion

Eligibility Criteria

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

You may qualify if:

  • post surgical or post traumatic scar on face or scalp
  • age 18 or older
  • able to read and comprehend English
  • Willing to follow treatment schedule and post treatment care requirements
  • signed informed consent form
  • Fitzpatrick skin type I-III

You may not qualify if:

  • known photosensitivity
  • taken any medications known to induce photosensitivity in previous three months
  • taken accutane within past 12 months
  • pregnant or nursing
  • currently on topical or oral antibiotics
  • immunocompromised status
  • skin type IV or greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cicatrix

Interventions

Lasers

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • John Christophel, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

March 1, 2010

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 4, 2023

Record last verified: 2023-10