To assess efficacy and safety of intense pulsed light (IPL) activation of silver nanoparticles (SNA) versus IPL alone for treatment of keratosis pilaris.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
10
IPL is an attractive option in the treatment of KP as the provider can utilize cut-off filters to target both melanin for hair removal and erythema with a single device. An added benefit of IPL is the larger crystal size, allowing for efficient coverage of a larger body surface area. IPL has been utilized in the treatment of KP and KP variants, with outcomes showing reductions in both erythema and texture.
Erythema Grading Scale by a blinded investigator to assess change (one for each arm)
Erythema grading scale (Right Arm) 0 No erythema 1. Mild erythema 2. Moderate erythema 3. Severe erythema 4. Very severe erythema Erythema grading scale (Left Arm) 0 No erythema 1. Mild erythema 2. Moderate erythema 3. Severe erythema 4. Very severe erythema
Time frame: Baseline, Day 30, Day 60, Day 90, Day 110
Textural Change Grading Scale by a blinded investigator (one for each arm)
Textural change grading scale ( Right Arm) 0 No textural change 1. Mild textural change 2. Moderate textural change 3. Severe textural change 4. Very severe textural change Textural change grading scale (Left Arm) 0 No textural change 1. Mild textural change 2. Moderate textural change 3. Severe textural change 4. Very severe textural change
Time frame: Baseline, Day 30, Day 60, Day 90, Day 110
Investigator Global Aesthetic Improvement Scale (IGAIS) by a blinded investigator
Blinded Physician Global Aesthetic Improvement Scale Rating Description 1. Very Much Improved- Optimal cosmetic result in this subject 2. Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. 3. Improved- Obvious improvement in appearance from initial condition, but a re- treatment is indicated. 4. No Change- The appearance is essentially the same as the original condition. 5. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated
Time frame: Day 30, Day 60, Day 90, Day 110
Subject Global Aesthetic Improvement Scale (SGAIS)
Subject Global Aesthetic Improvement Scale Assessment How would you rate the overall change in appearance of your treated areas? Non-treated areas will be checked as "Not Treated" for you. Rating Description 1. Very Much Improved- Optimal cosmetic result in this subject 2. Much Improved- Marked improvement in appearance form the initial condition, but not completely optimal for this subject. 3. Improved- Obvious improvement in appearance from initial condition, but a re-treatment is indicated. 4. No Change- The appearance is essentially the same as the original condition. 5. Worse- The appearance is worse than the original condition. Scores (write a number under each treated area or check "Not Treated") Right Arm Left Arm Not Treated Not Treated
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Time frame: Day 30, Day 60, Day 90, Day 110