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Clinical Trial Summary

To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.


Clinical Trial Description

The primary objective of this pilot study is to assess efficacy and safety of intense pulsed light (IPL; StellarM22™ Universal IPL, Lumenis Ltd., Yokneam, Israel) alone versus combination of IPL activation of silver nanoparticles (SNA) for treatment of keratosis pilaris. Prior to first treatment, right and left arms of 10 enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm). The intervention arm will be pre-treated with sugaring to epilate existing hair. This arm will then be treated with 0.5mL of nanoparticle suspension administered with a standard infusion paddle for 5 minutes prior to IPL treatment. Following nanoparticle infusion, excess suspension will be removed from the surface of the skin with a pre-moistened wipe. Once all visible suspension is removed from the skin, the area will be cleansed with an alcohol wipe. If the alcohol wipe shows that the suspension is still present on the surface of the skin, additional pre-moistened wipes will be used to cleanse the skin until the alcohol wipe comes away without visible suspension. IPL will then be applied to the intervention arm. Treatments will be repeated three times, spaced four- to six-weeks apart. After completing all three treatments, patients will return for macroscopic and dermoscopic photography at 1 month and 3 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05666011
Study type Interventional
Source Goldman, Butterwick, Fitzpatrick and Groff
Contact Andrea Pacheco
Phone 8586571004
Email apacheco@clderm.com
Status Not yet recruiting
Phase N/A
Start date March 20, 2023
Completion date May 30, 2023

See also
  Status Clinical Trial Phase
Completed NCT04797663 - Long-pulsed 1064 nm Nd-YAG Laser Versus TCA 20% in Treatment of Keratosis Pilaris Phase 4
Terminated NCT00944216 - Efficacy and Safety of Salkera Emollient Foam in the Treatment of Moderate to Severe Keratosis Pilaris, a Prospective Study Phase 4
Active, not recruiting NCT06032078 - Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris N/A
Completed NCT03243617 - Cosmetic Study of AO+Mist in Improving the Appearance of Skin Afflicted With Keratosis Pilaris N/A
Recruiting NCT05535517 - Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris