Status:

UNKNOWN

Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris

Lead Sponsor:

Premier Specialists, Australia

Collaborating Sponsors:

The University of New South Wales

Conditions:

Keratosis Pilaris

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This prospective study aims to evaluate the responsiveness of the validated investigator global assessment (IGA) and composite area index score for keratosis pilaris by data collection through treatme...

Detailed Description

This is a prospective study aiming to evaluate the responsiveness of the IGA score for KP. KPAI is a 5-point IGA score (0-4) of five main body areas: face, upper limbs, lower limbs, trunk, and buttock...

Eligibility Criteria

Inclusion

  • All genders are allowed to participate
  • Age range: 18-80 years
  • Participants with Fitzpatrick skin type 1-3
  • Those with KP including subtypes of KP on the scored body regions (face, upper limbs, lower limbs, trunk, and buttocks)
  • Able to attend the scoring sessions
  • Participants having read and understood the PICF and are willing to participate
  • Of mature mind and able to provide informed consent
  • Able to maintain compliance with required study related procedures including completing the QOL questionnaire's

Exclusion

  • Participants who are unwilling or unable to attend the scoring sessions
  • Those with other skin conditions overlapping the same area(s) as the KP
  • People younger than 18
  • People with darker skin i.e. Fitzpatrick skin type 4 or above
  • Those who had received any laser or dermabrasion therapy in the previous 6 months or topical treatment (keratolytic agents or corticosteroids) in the previous 1 month before the study treatment session
  • Those with a history of keloid or hypertrophic scars
  • Those being on photosensitive medications, allergic to intervention agents
  • Pregnant or lactating

Key Trial Info

Start Date :

July 26 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 29 2023

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT06032078

Start Date

July 26 2023

End Date

December 29 2023

Last Update

September 11 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Premier Dermatology

Sydney, New South Wales, Australia, 2217

2

Premier Specialists

Sydney, New South Wales, Australia, 2217