Keratosis PilarisNCT05535517
Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
An observational study of Keratosis Pilaris, run by Premier Specialists, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratosis Pilaris
- What is being tested?
- CeraVe SA Smoothing Cleanser, CeraVe SA Smoothing Cream and Propaira 20% Lactic Acid Exfoliating Lotion
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Aug 2022to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of the Principal Investigator's dermatology practice who have been diagnosed with keratosis pilaris.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Premier Specialists
Kogarah, New South Wales, 2222
Bianca Wills, BMedSci, 9598 5800, premierspectrialsbianca@gmail.com
Madeline Wang
About this study
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.
Read the 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.
- Conditions
- Keratosis Pilaris
- Being tested
- CeraVe SA Smoothing Cleanser, CeraVe SA Smoothing Cream, Propaira 20% Lactic Acid Exfoliating Lotion, Propaira 30% Urea Exfoliating Emollient, KPAI
- Keywords
- scoring system, IGA score, severity, disease assessment, KP, evaluation
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraVe SA Smoothing CleanserOther
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 CreamOther
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 LotionOther
For smoothing rough skin.
Propaira 30% Urea Exfoliating EmollientOther
30% Urea, 7% Glycerin to smoothen rough skin.
KPAIOther
Also called Keratosis Pilaris Area Index
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-IGAOther
A standard 5-point IGA score (0-4) defined specifically for KP
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | KP Scoring Day Participants
Participants who attend the one-day scoring session in August 2022. Receives: Other: KPAI; Other: KP-IGA | |
| 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. Receives: Other: CeraVe SA Smoothing Cleanser; Other: CeraVe SA Smoothing Cream; Other: KPAI; Other: KP-IGA | |
| 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. Receives: Other: Propaira 20% Lactic Acid Exfoliating Lotion; Other: Propaira 30% Urea Exfoliating Emollient; Other: KPAI; Other: KP-IGA | |
| 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. Receives: Other: KPAI; Other: KP-IGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
QOL questionnaires (DLQI/CDLQI)
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.
Measured: through study completion, an average of 1 year
QOL questionnaires (HADS)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start13 Aug 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratosis PilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premier Specialists, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dedee Murrell, Premier Specialists, Australia
- Investigators
- Dédée Murrell, Principal investigator, Premier Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535517
- Sponsor's protocol ID
- KPIGA2022
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24355263
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris
- ClinicalTrials.gov ID
- NCT05535517
- Acronym / sponsor ID
- KPIGA2022
- Conditions
- Keratosis Pilaris
- Keywords
- scoring system, IGA score, severity, disease assessment, KP, evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Premier Specialists, AustraliaUniversity, hospital or other
- Study start
- 13 Aug 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: KPAI, Other: KP-IGAKP Scoring Day Participants Participants who attend the one-day scoring session in August 2022. |
| Group 2 | – | Other: CeraVe SA Smoothing Cleanser, Other: CeraVe SA Smoothing Cream, Other: KPAI, Other: KP-IGAKP 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 | – | Other: Propaira 20% Lactic Acid Exfoliating Lotion, Other: Propaira 30% Urea Exfoliating Emollient, Other: KPAI, Other: KP-IGAKP 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 | – | Other: KPAI, Other: KP-IGAKP 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. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the Principal Investigator's dermatology practice who have been diagnosed with keratosis pilaris.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeraVe SA Smoothing CleanserThe 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 | Group 2 |
| CeraVe SA Smoothing CreamThe CeraVe Salicylic Acid (SA) Smoothing Cream contains salicylic acid as well as hydrating hyaluronic acid and three essential ceramides. | Other | Group 2 |
| Propaira 20% Lactic Acid Exfoliating LotionFor smoothing rough skin. | Other | Group 3 |
| Propaira 30% Urea Exfoliating Emollient30% Urea, 7% Glycerin to smoothen rough skin. | Other | Group 3 |
| KPAIAlso: Keratosis Pilaris Area IndexThe 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 | Group 1, Group 2, Group 3, Group 4 |
| KP-IGAA standard 5-point IGA score (0-4) defined specifically for KP | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Keratosis Pilaris Area Index (KPAI)
Time frame: 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.
2 secondary outcomes
QOL questionnaires (DLQI/CDLQI)
Time frame: through study completion, an average of 1 year
QOL questionnaires (HADS)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 24355263Loh 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.
- Individual participant dataSharing planned: Undecided
Related trials for Keratosis Pilaris
Recruiting
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
Keratosis Pilaris (KP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dédée Murrell principal investigator
Premier Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratosis Pilaris, run by Premier Specialists, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bianca Wills, BMedSci (0452409850, premierspectrialsbianca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratosis Pilaris Area Index (KPAI) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535517, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.