NCT00955461

Brief Summary

The purpose of this study is to compare the results of treatment between the side of the face treated with the RevLite Laser and the side of the face treated with a fractionated laser system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration 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

First Submitted

Initial submission to the registry

August 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

2.2 years

First QC Date

August 6, 2009

Last Update Submit

November 27, 2012

Conditions

PhotodamageIrregular PigmentationAcne Scars

Outcome Measures

Primary Outcomes (1)

  • Assessment of the percentage of overall, cumulative improvement from Baseline in the appearance of wrinkles, skin tone and/or texture, pigmentation and acne scars

    3 and 6 months post final treatment

Study Arms (1)

Laser treatment

EXPERIMENTAL

Split-Face Comparison of an Electro-optic Q-Switched Nd: YAG Laser to a Fractionated Laser

Procedure: RevLite laser treatmentProcedure: Fractionated Laser treatment

Interventions

RevLite laser treatmentPROCEDURE

Electro-optic Q-Switched Nd: YAG Laser treatment

Laser treatment
Fractionated Laser treatmentPROCEDURE
Laser treatment

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fitzpatrick Skin Type I-VI and Wrinkle Class I
  • Between the ages of 25-65
  • Evidence of bilateral dyschromia

You may not qualify if:

  • Pregnant, lactating, or is planning to become pregnant
  • history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
  • any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical or systemic therapy
  • coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
  • any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
  • currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
  • unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
  • unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
  • Accutane within 6 months
  • need to be exposed to artificial tanning devices or excessive sunlight during the trial
  • prior treatment with parenteral gold therapy
  • Diabetes Type 1 or 2
  • does not agree to refrain from any other type of facial skin resurfacing (e.g., microdermabrasion, laser or IPL treatment, chemical peel) or injected fillers/other substances (e.g., Restylane, Botox) that might affect the treatment area for the duration of the study
  • artificial tanning within 1 month
  • (micro)dermabrasion within 3 months
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

Study Officials

  • Neil Sadick, MD

    Sadick Research Group

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 10, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

US(1)