NCT01176448

Brief Summary

Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 27, 2013

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

June 21, 2010

Results QC Date

November 9, 2011

Last Update Submit

October 30, 2019

Conditions

CicatrixDermabrasionCoagulation, Laser

Keywords

CicatrixDermabrasionCoagulation, Laser

Outcome Measures

Primary Outcomes (1)

  • Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing

    Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.

    Day 0, Week1, Month 1

Secondary Outcomes (1)

  • Visual Analog Scale for Assessing Scar Improvement.

    3 months

Study Arms (2)

Fractionated laser

EXPERIMENTAL

This Arm is the section of scar that will be treated with Fractionated Laser

Device: Fractionated laser

Dermabrasion

ACTIVE COMPARATOR

Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.

Device: Dermabrasion

Interventions

Fractionated laserDEVICE

Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.

Fractionated laser
DermabrasionDEVICE

Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.

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 the 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

Study Sites (1)

Zel Skin and Laser

Edina, Minnesota, 55424, United States

Location

Related Publications (1)

  • Jared Christophel J, Elm C, Endrizzi BT, Hilger PA, Zelickson B. A randomized controlled trial of fractional laser therapy and dermabrasion for scar resurfacing. Dermatol Surg. 2012 Apr;38(4):595-602. doi: 10.1111/j.1524-4725.2011.02283.x. Epub 2012 Jan 23.

    PMID: 22268699DERIVED

MeSH Terms

Conditions

CicatrixThrombosis

Interventions

Dermabrasion

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsDermatologic Surgical ProceduresPlastic Surgery ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
J. Jared Christophel MD
Organization
University of Virginia Dept of Otolaryngology Head and Neck Surgery
jjchristop@gmail.com
434-243-9391

Study Officials

  • John J Christophel, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2010

First Posted

August 6, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

November 1, 2019

Results First Posted

June 27, 2013

Record last verified: 2019-10

Locations

US(1)