UnknownNot Applicable

Development and Validation of an Investigator Global Assessment Score for Keratosis Pilaris

Australia15 participantsStarted 2022-08-13

Plain-language 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.

Who can participate

Age range

12 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Keratosis Pilaris Area Index (KPAI)

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05535517

SponsorPremier Specialists, Australia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-30

Contact for this trial

Bianca Wills, BMedSci

0452409850 premierspectrialsbianca@gmail.com

View on ClinicalTrials.gov More Keratosis Pilaris trials