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

Goldman, Butterwick, Fitzpatrick and Groff

Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline.

Cutera laser machine

This prospective study aims to evaluate the responsiveness of the validated investigator global assessment (IGA) and composite area index score for keratosis pilaris by data collection through treatment and scoring sessions held at a private practice and relevant statistical analysis.

This is a prospective study aiming to evaluate the responsiveness of the IGA score for KP. KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100. KPIGA, on the other hand, is a standard 0-4 IGA score. A Physician's Global Assessment Score and a 15-point Likert Scale would also be used by investigators, data collected act as external anchor for further responsiveness statistical analysis purpose.

4 scoring sessions will take place at Premier Specialists, Kogarah, Sydney with all co-investigators conducting the study in person at this single study site. Each dermatologist and medical professional involved will receive training on using the scores through a slideshow of training photos prior to the live scoring session. Firstly, a baseline score will be determined using the proposed scoring systems on the first scoring session. After that, participants will be offered 3 sessions of Nd: YAG laser 1064nm treatments at 4-week intervals on the affected skin of all body regions (face, upper limbs, lower limbs, trunk, and buttocks). The baseline KPIGA and KPAI scores obtained on the first scoring visit acts as the control for this pilot study and the scores obtained in the 3 progressive visits will be compared to the baseline. According to relevant study, the recommended Nd: YAG laser 1064nm treatment regimen is 3 treatment sessions at 4-week intervals. They will be scored before subsequent treatment sessions to see if there is any improvement in their KP and if the score is responsive to change.

Every participant will also complete the DLQI questionnaire during each visit. This data will be used to provide insight of patient's subjective perceptions of KP and the psychological impact it may have on them.

15 patients with keratosis pilaris (including subtypes) are recruited

Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris

Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis

All data obtained will be stored securely on-site premises and will not be articulated outside of Australia. Data obtained from patients through scoring sheets and QOL questionnaires will be transcribed as de-identifiable data in an Excel spreadsheet into a password-protected computer (only the investigators with the corresponding study codes given to each patient can identify the data for the purpose of study data analysis). The original scoring sheets and QOL questionnaires will be stored securely on-site and may only be accessed by investigators and co-investigators, as detailed in the patient consent form.

KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100.

15-point Likert scale from -7 (deterioration) to +7 (improvement)

10-point scale form 0 to 10 showing the worst skin condition to the best

The University of New South Wales

Premier Specialists, Australia

Professor Dedee Murrell

All Drugs and Chemicals

Anti-Infective Agents

Dermatologic Agents

Antiemetics

Gastrointestinal Agents

Hyaluronic Acid

Salicylic Acid

Dimenhydrinate

Carbamide Peroxide

Emollients

Immunoglobulin A

KP Scoring Day Participants

Participants who attend the one-day scoring session in August 2022.

KP Follow-up Scoring (September)

Participants who attended the scoring day in August will be invited to attend a follow-up scoring session in September - October 2022. The purpose of this scoring session is to see how stable their condition is and take baseline photographs of their skin to monitor their condition.

Four assessors will score the participants in 5-minute intervals with the proposed scoring system KPAI and the KP-IGA. Participants will be offered free samples of Cerave Salicylic Acid Smoothing Cleanser and Cream to try.

KP Follow-up Scoring (November)

Participants who attend the September scoring session will be invited to return for another rescoring in November - December 2022 to see if there is any improvement in their KP and if the score is responsive to change.

Participants will be given free samples of Propaira 30% Urea exfoliating emollient and Propaira 20% Lactic acid exfoliating lotion to try.

KP Follow-up Scoring (December)

Participants who attend the November scoring session will be invited to return for another rescoring in December 2022 to monitor their progress, and see if there is any improvement in their KP and if the score is responsive to change.

The CeraVe Salicylic Acid (SA) Smoothing Cleanser is formulated with salicylic acid to help exfoliate the skin and remove dirt and dead skin cells on the skin without compromising or striping moisture from the skin's natural barrier, leaving the skin feeling clean, smooth and hydrated. This salicylic acid cleanser is also formulated to include hyaluronic acid to hydrate and retain moisture and 3 essential ceramides to moisturise and help support the skin's barrier.

CeraVe SA Smoothing Cleanser

The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides.

CeraVe SA Smoothing Cream

Propaira 20% Lactic Acid Exfoliating Lotion

30% Urea, 7% Glycerin to smoothen rough skin.

Propaira 30% Urea Exfoliating Emollient

The proposed score, Keratosis Pilaris Area Index (KPAI), is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100.

KPAI

A standard 5-point IGA score (0-4) defined specifically for KP

KP-IGA

Bianca Wills, BMedSci

Madeline Wang

Anna Wilson

Dédée Murrell

This validation study aims to develop a standardised investigator global assessment (IGA) score for keratosis pilaris and test the validity and reliability of the score through a one-day scoring exercise held at a private practice and compare it to a standard 0-4 IGA score specifically defined for keratosis pilaris.

This is a prospective validation study aiming to develop and validate a standardised IGA score for KP. Firstly, a preliminary score will be developed using deidentified photos of patients with KP. These photos will only be used to create the training slide for the assessors. The proposed score, Keratosis Pilaris Area Index (KPAI), is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttocks, for a maximum of 20 in two main categories, activity (erythema, skin roughness and papulation) and damage (pigmentation and scarring). The final score will be a maximum of 100. This will be compared to a standard 0-4 IGA score, defined specifically for KP, known as a KP-IGA.

The one-day scoring exercise has been modified from the Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) validation (Loh et al., 2014). It will take place at Premier Specialists, Kogarah, Sydney with all co-investigators conducting the study in person at this single study site. Each dermatologist and medical professional involved will receive training on using the scores through a slideshow of training photos prior to the live scoring session. Five dermatologists and four medical professionals will be randomly assigned to assess 20 KP patients in 5-minute intervals, using the proposed scoring system, KPAI, and the KP-IGA score. This data will be used to assess inter-rater reliability.

Each dermatologist or medical professional will be randomly assigned to rescore two patients after seeing other patients to minimise recall bias. The randomisation will be done by an investigator who is uninvolved in the scoring session and has had no interaction with both patients and assessors. Data gathered from this section is used to determine intra-rater reliability.

Every participant will also complete two QOL questionnaires: the DLQI/CDLQI and HADS. This data will be used to provide insight of patient's subjective perceptions of KP and the psychological impact it may have on them.

Participants who attended the scoring day will be invited to attend a follow-up scoring session in September - October 2022. The purpose of this scoring session is to see how stable their condition is and take baseline photographs of their skin to monitor their condition.

Four assessors will score the participants in 5-minute intervals with the proposed scoring system KPAI and the KP-IGA. Participants will be offered free samples of Cerave Salicylic Acid Smoothing Cleanser and Cream to try. They will be invited to return for another rescoring in November - December 2022 to see if there is any improvement in their KP and if the score is responsive to change.

In the November - December 2022 scoring session, participants will be given free samples of Propaira 30% Urea exfoliating emollient and Propaira 20% Lactic acid exfoliating lotion to try. They will be invited to return for a fourth scoring session in December to monitor their progress and see if the scores improve.

Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris

This study aims to develop and validate an IGA score for evaluating KP (KPAI) by determining the intra-rater and inter-rater reliability through testing the composite IGA score on patients and comparing it to a standard 0-4 IGA that will be defined specifically for KP.

The secondary aim of the study is to explore the impact KP may have on patients' QOL by using the (Child) Dermatology Life Quality (DLQI/CDLQI) Index questionnaires.

The secondary aim of the study is to explore the impact KP may have on patients' QOL by using the hospital anxiety and depression scale (HADS) questionnaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laser to Aid in Treatment of Keratosis Pilaris on Arms	NCT05666011	Keratosis Pilar...	M22 IPL	18 Years -	Goldman, Butterwick, Fitzpatrick and Groff
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris	NCT06032078	Keratosis Pilar...	Cutera laser ma...	18 Years -	Premier Specialists, Australia
Laser to Aid in Treatment of Keratosis Pilaris on Arms	NCT05666011	Keratosis Pilar...	M22 IPL	18 Years -	Goldman, Butterwick, Fitzpatrick and Groff
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris	NCT05535517	Keratosis Pilar...	CeraVe SA Smoot... CeraVe SA Smoot... Propaira 20% La... Propaira 30% Ur... KPAI KP-IGA	12 Years - 80 Years	Premier Specialists, Australia

Spots Global Cancer Trial Database for keratosis pilaris