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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05535517




Registration number
NCT05535517
Ethics application status
Date submitted
30/08/2022
Date registered
10/09/2022
Date last updated
10/09/2022

Titles & IDs
Public title
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
Scientific title
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
Secondary ID [1] 0 0
KPIGA2022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keratosis Pilaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - CeraVe SA Smoothing Cleanser
Other interventions - CeraVe SA Smoothing Cream
Other interventions - Propaira 20% Lactic Acid Exfoliating Lotion
Other interventions - Propaira 30% Urea Exfoliating Emollient
Other interventions - KPAI
Other interventions - KP-IGA

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.


Other interventions: 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 interventions: 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 interventions: Propaira 20% Lactic Acid Exfoliating Lotion
For smoothing rough skin.

Other interventions: Propaira 30% Urea Exfoliating Emollient
30% Urea, 7% Glycerin to smoothen rough skin.

Other interventions: 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 interventions: KP-IGA
A standard 5-point IGA score (0-4) defined specifically for KP
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Keratosis Pilaris Area Index (KPAI)
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [1] 0 0
QOL questionnaires (DLQI/CDLQI)
Timepoint [1] 0 0
through study completion, an average of 1 year
Secondary outcome [2] 0 0
QOL questionnaires (HADS)
Timepoint [2] 0 0
through study completion, an average of 1 year

Eligibility
Key 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
Minimum age
12 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment postcode(s) [1] 0 0
2222 - Kogarah

Funding & Sponsors
Primary sponsor type
Other
Name
Premier Specialists, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT05535517
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Dédée Murrell
Address 0 0
Premier Specialists
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bianca Wills, BMedSci
Address 0 0
Country 0 0
Phone 0 0
0452409850
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05535517