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

NCT06032078 | Unknown

• 1 other identifier: 2022-04-376-A-3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 treatment and scoring sessions held at a private practice and relevant statistical analysis.

Conditions

Keratosis Pilaris

Keywords

responsiveness; investigator global assessment

Outcome Measures

Primary Outcomes (4)

• KP-IGA

  KP-IGA is a standard 0-4 IGA score.

  through study completion, an average of 1 year

• KPAI

  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.

  through study completion, an average of 1 year

• Likert Scale of Magnitude of CHange

  15-point Likert scale from -7 (deterioration) to +7 (improvement)

  through study completion, an average of 1 year

• Physician's Global Assessment

  10-point scale form 0 to 10 showing the worst skin condition to the best

  through study completion, an average of 1 year

Study Arms (1)

Patients with keratosis pilaris

EXPERIMENTAL

Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline.

Device: Cutera laser machine

Interventions

Cutera laser machine DEVICE

1064nm Nd: YAG laser

Patients with keratosis pilaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Premier Specialists, Australia: lead
• The University of New South Wales: collaborator

Study Sites (2)

Premier Dermatology

Sydney, New South Wales, 2217, Australia

Location

Premier Specialists

Sydney, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Burnett Schwartz Berberian syndrome

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dedee Murrell

Model Details: 15 patients with keratosis pilaris (including subtypes) are recruited

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 11, 2023
• Study Start: July 26, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)