Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
NCT ID: NCT05535517
Last Updated: 2022-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2022-08-13
2023-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1
KP Scoring Day Participants
Participants who attend the one-day scoring session in August 2022.
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.
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.
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.
CeraVe SA Smoothing Cream
The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides.
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.
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.
Propaira 20% Lactic Acid Exfoliating Lotion
For smoothing rough skin.
Propaira 30% Urea Exfoliating Emollient
30% Urea, 7% Glycerin to smoothen rough skin.
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.
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.
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.
KP-IGA
A standard 5-point IGA score (0-4) defined specifically for KP
Interventions
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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.
CeraVe SA Smoothing Cream
The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides.
Propaira 20% Lactic Acid Exfoliating Lotion
For smoothing rough skin.
Propaira 30% Urea Exfoliating Emollient
30% Urea, 7% Glycerin to smoothen rough skin.
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.
KP-IGA
A standard 5-point IGA score (0-4) defined specifically for KP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Those with other skin conditions overlapping the same area(s) as the KP
12 Years
80 Years
ALL
Yes
Sponsors
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Premier Specialists, Australia
OTHER
Responsible Party
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Dedee Murrell
Professor, Director of Premier Specialists
Principal Investigators
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Dédée Murrell
Role: PRINCIPAL_INVESTIGATOR
Premier Specialists
Locations
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Premier Specialists
Kogarah, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Loh CC, Kim J, Su JC, Daniel BS, Venugopal SS, Rhodes LM, Intong LR, Law MG, Murrell DF. Development, reliability, and validity of a novel Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI). J Am Acad Dermatol. 2014 Jan;70(1):89-97.e1-13. doi: 10.1016/j.jaad.2013.09.041.
Other Identifiers
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KPIGA2022
Identifier Type: -
Identifier Source: org_study_id
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