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

Sponsor

Premier Specialists, Australia (Other)

Overall Status

Recruiting

CT.gov ID

NCT05535517

Collaborator

(none)

Enrollment

Location

12.6

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Keratosis Pilaris	Other: CeraVe SA Smoothing Cleanser Other: CeraVe SA Smoothing Cream Other: Propaira 20% Lactic Acid Exfoliating Lotion Other: Propaira 30% Urea Exfoliating Emollient Other: KPAI Other: KP-IGA

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

15 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 13, 2022

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group 1 KP Scoring Day Participants Participants who attend the one-day scoring session in August 2022.	Other: KPAI 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. Other Names: Keratosis Pilaris Area Index Other: KP-IGA A standard 5-point IGA score (0-4) defined specifically for KP
Group 2 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.	Other: CeraVe SA Smoothing Cleanser 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. Other: CeraVe SA Smoothing Cream The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides. Other: KPAI 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. Other Names: Keratosis Pilaris Area Index Other: KP-IGA A standard 5-point IGA score (0-4) defined specifically for KP
Group 3 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.	Other: Propaira 20% Lactic Acid Exfoliating Lotion For smoothing rough skin. Other: Propaira 30% Urea Exfoliating Emollient 30% Urea, 7% Glycerin to smoothen rough skin. Other: KPAI 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. Other Names: Keratosis Pilaris Area Index Other: KP-IGA A standard 5-point IGA score (0-4) defined specifically for KP
Group 4 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.	Other: KPAI 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. Other Names: Keratosis Pilaris Area Index Other: KP-IGA A standard 5-point IGA score (0-4) defined specifically for KP

Outcome Measures

Primary Outcome Measures

Keratosis Pilaris Area Index (KPAI) [through study completion, an average of 1 year]
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.

Secondary Outcome Measures

QOL questionnaires (DLQI/CDLQI) [through study completion, an average of 1 year]
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.
QOL questionnaires (HADS) [through study completion, an average of 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All genders are allowed to participate
Age range: 12-80 years
Those with KP including subtypes of KP
Able to attend the one-day scoring session
Participants having read and understood the patient information and consent form and are willing to participate
Of mature mind and able to provide informed consent, in case of children (< 18 years) then the guardian or caretaker can provide consent
Able to maintain compliance with required study related procedures including completing the QOL questionnaire's