Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Rare Diseases

Keratosis, Actinic

Keratosis

Congenital Abnormalities

Abnormalities, Multiple

Darier Disease

Skin Diseases

Precancerous Conditions

Skin Diseases, Genetic

Genetic Diseases, Inborn

Right Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and left arm with IPL alone.

Left Arm will be treated with IPL activation of SNA (Silver Nanoparticles ) and right arm with IPL alone.

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.

M22 IPL

Andrea Pacheco

Sherif Mikhail, MD

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.

Enrolled subjects will be randomized to combination treatment with IPL activation of SNA (i.e. intervention arm) versus IPL alone (i.e. control arm).

Blinded Investigator will be unaware of which arm received which treatment

Laser to Aid in Treatment of Keratosis Pilaris on Arms

A Single Center, Evaluator-Blinded, Split-Body, Randomized Pilot Study of Intense Pulsed Light Activation of Silver Nanoparticles vs. Intense Pulsed Light Alone in the Treatment of Keratosis Pilaris

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Laser to Aid in Treatment of Keratosis Pilaris on Arms	NCT05666011	Keratosis Pilar...	M22 IPL	18 Years -	Goldman, Butterwick, Fitzpatrick and Groff
Laser to Aid in Treatment of Keratosis Pilaris on Arms	NCT05666011	Keratosis Pilar...	M22 IPL	18 Years -	Goldman, Butterwick, Fitzpatrick and Groff

Spots Global Cancer Trial Database for m22 ipl

Every month we try and update this database with for m22 ipl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for m22 ipl

Every month we try and update this database with for m22 ipl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for m22 ipl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.