Trial Title:
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
NCT ID:
NCT05535517
Condition:
Keratosis Pilaris
Conditions: Official terms:
Keratosis, Actinic
Abnormalities, Multiple
Darier Disease
Keratosis
Emollients
Conditions: Keywords:
scoring system
IGA score
severity
disease assessment
KP
evaluation
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
CeraVe SA Smoothing Cleanser
Description:
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.
Arm group label:
Group 2
Intervention type:
Other
Intervention name:
CeraVe SA Smoothing Cream
Description:
The CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as
hydrating hyaluronic acid and three essential ceramides.
Arm group label:
Group 2
Intervention type:
Other
Intervention name:
Propaira 20% Lactic Acid Exfoliating Lotion
Description:
For smoothing rough skin.
Arm group label:
Group 3
Intervention type:
Other
Intervention name:
Propaira 30% Urea Exfoliating Emollient
Description:
30% Urea, 7% Glycerin to smoothen rough skin.
Arm group label:
Group 3
Intervention type:
Other
Intervention name:
KPAI
Description:
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.
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
Arm group label:
Group 4
Other name:
Keratosis Pilaris Area Index
Intervention type:
Other
Intervention name:
KP-IGA
Description:
A standard 5-point IGA score (0-4) defined specifically for KP
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
Arm group label:
Group 4
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.
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.
Criteria for eligibility:
Study pop:
Patients of the Principal Investigator's dermatology practice who have been diagnosed
with keratosis pilaris.
Sampling method:
Non-Probability Sample
Criteria:
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
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
Gender:
All
Minimum age:
12 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Premier Specialists
Address:
City:
Kogarah
Zip:
2222
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Bianca Wills, BMedSci
Phone:
9598 5800
Email:
premierspectrialsbianca@gmail.com
Investigator:
Last name:
Madeline Wang
Email:
Sub-Investigator
Investigator:
Last name:
Anna Wilson
Email:
Sub-Investigator
Investigator:
Last name:
Dédée Murrell
Email:
Principal Investigator
Start date:
August 13, 2022
Completion date:
August 30, 2023
Lead sponsor:
Agency:
Premier Specialists, Australia
Agency class:
Other
Source:
Premier Specialists, Australia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05535517
