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

NCT05535517 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2022-09-10

No results posted yet for this study

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.

Conditions

  • Keratosis Pilaris

Interventions

OTHER

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

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

Propaira 20% Lactic Acid Exfoliating Lotion

For smoothing rough skin.

OTHER

Propaira 30% Urea Exfoliating Emollient

30% Urea, 7% Glycerin to smoothen rough skin.

OTHER

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

KP-IGA

A standard 5-point IGA score (0-4) defined specifically for KP

Sponsors & Collaborators

  • Premier Specialists, Australia

    lead OTHER

Principal Investigators

  • Dédée Murrell · Premier Specialists

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-13
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05535517 on ClinicalTrials.gov