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Impact of Synergistic Sequential Treatment (SST)

NCT01940445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2017-01-26

No results posted yet for this study

Summary

At least thirty (30) subjects, Fitzpatrick-Goldman Skin Type II-V will be enrolled in 2 clinical sites; each clinic will enroll at least 15 subjects.

Subjects should present visible wrinkles and/or elastosis requiring treatment.

Hypothesis: The SST will improve the appearance of the wrinkles/elastosis as well as general skin tone by at least 25% as compared to M22 ResurFX 1565nm module alone, for at least 75% of the subjects.

Conditions

  • Improvement of Wrinkles/Elastosis as Well as General Skin Tone

Interventions

DEVICE

M22 ResurFX

Fractional NA treatment (ResurFX) on one side of the face

DEVICE

M22 ResurFX and QS

Fractional NA treatment followed by QS laser treatment (SST) on one side of the face

Sponsors & Collaborators

  • Lumenis Be Ltd.

    lead INDUSTRY

Principal Investigators

  • Girish (Gilly) Munavalli, MD · Dermatology, Laser, and Vein Specialists of the Carolinas, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940445 on ClinicalTrials.gov