Clinical trial NCT06032078: Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris
Official title: Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Keratosis Pilaris
Keywords: responsiveness
investigator global assessment
Lead sponsor: Premier Specialists, Australia
Sponsor class: OTHER
Collaborators: name: The University of New South Wales
First posted: 2023-09-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 15 patients with keratosis pilaris (including subtypes) are recruited
Primary purpose: OTHER

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.

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 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Participants who are unwilling or unable to attend the scoring sessions
2. Those with other skin conditions overlapping the same area(s) as the KP
3. People younger than 18
4. People with darker skin i.e. Fitzpatrick skin type 4 or above
5. 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
6. Those with a history of keloid or hypertrophic scars
7. Those being on photosensitive medications, allergic to intervention agents
8. Pregnant or lactating

Primary outcomes:
measure: KP-IGA
timeFrame: through study completion, an average of 1 year
measure: KPAI
timeFrame: through study completion, an average of 1 year
measure: Likert Scale of Magnitude of CHange
timeFrame: through study completion, an average of 1 year
measure: Physician's Global Assessment
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Premier Dermatology
state: New South Wales
city: Sydney
country: Australia
facility: Premier Specialists
state: New South Wales
Study officials:
References: