Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2022
CompletedFirst Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedSeptember 10, 2022
September 1, 2022
1 year
August 30, 2022
September 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Keratosis Pilaris Area Index (KPAI)
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.
through study completion, an average of 1 year
Secondary Outcomes (2)
QOL questionnaires (DLQI/CDLQI)
through study completion, an average of 1 year
QOL questionnaires (HADS)
through study completion, an average of 1 year
Study Arms (4)
Group 1
KP Scoring Day Participants Participants who attend the one-day scoring session in August 2022.
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.
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.
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.
Interventions
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.
The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides.
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.
A standard 5-point IGA score (0-4) defined specifically for KP
Eligibility Criteria
Patients of the Principal Investigator's dermatology practice who have been diagnosed with keratosis pilaris.
You may qualify if:
- 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
You may not qualify if:
- Participants who are unwilling or unable to attend the one-day scoring session
- Those with other skin conditions overlapping the same area(s) as the KP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Premier Specialists
Kogarah, New South Wales, 2222, Australia
Related Publications (1)
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.
PMID: 24355263BACKGROUND
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Dédée Murrell
Premier Specialists
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Premier Specialists
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 10, 2022
Study Start
August 13, 2022
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
September 10, 2022
Record last verified: 2022-09