NCT02032771

Impact of M22 Synergistic Sequential Treatment (SST)

Impact of M22 Synergistic Sequential Treatment (SST) Using Intense Pulsed Light and Fractional Non-ablative Photothermolysis on Skin Texture

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Up to 40 healthy subjects at 2 sites, age 30-65 year old with Fitzpatrick-Elastosis score of 3-6 and mild to moderate age/sun-related facial pigmentation that wish to improve their facial skin appearance. Hypothesis: The SST will improve the appearance of the wrinkles/elastosis and/or pigmentation by at least 1 on the FES scale or ≥50% in category scale at 3 months follow-ups in at least 50% of the study population.

Conditions

• Improvement of Wrinkles/Elastosis and/or Pigmentation

Interventions

Type	Name	Description
DEVICE	M22 IPL and ResurFX	The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment.

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-01-10
• Last updated: 2016-09-16

Locations

2 sites across 2 countries: United States, Germany