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

Premier Specialists, Australia

Status

Active, not recruiting

Conditions

Keratosis Pilaris

Treatments

Device: Cutera laser machine

Study type

Interventional

Funder types

Other

Identifiers

NCT06032078

2022-04-376-A-3

Details and patient eligibility

About

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.

Full 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 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. KPIGA, on the other hand, is a standard 0-4 IGA score. A Physician's Global Assessment Score and a 15-point Likert Scale would also be used by investigators, data collected act as external anchor for further responsiveness statistical analysis purpose.

4 scoring sessions 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. Firstly, a baseline score will be determined using the proposed scoring systems on the first scoring session. After that, participants will be offered 3 sessions of Nd: YAG laser 1064nm treatments at 4-week intervals on the affected skin of all body regions (face, upper limbs, lower limbs, trunk, and buttocks). The baseline KPIGA and KPAI scores obtained on the first scoring visit acts as the control for this pilot study and the scores obtained in the 3 progressive visits will be compared to the baseline. According to relevant study, the recommended Nd: YAG laser 1064nm treatment regimen is 3 treatment sessions at 4-week intervals. They will be scored before subsequent treatment sessions to see if there is any improvement in their KP and if the score is responsive to change.

Every participant will also complete the DLQI questionnaire during each visit. This data will be used to provide insight of patient's subjective perceptions of KP and the psychological impact it may have on them.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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