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

Keratosis Pilaris Clinical Trial

Official title:

Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06032078
• Other study ID #: 2022-04-376-A-3
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: December 29, 2023

Study information

• Verified date: September 2023
• Source: Premier Specialists, Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis Pilaris
• Keratosis, Actinic

Intervention

Device:
• Cutera laser machine
1064nm Nd: YAG laser

Locations

Country	Name	City	State
Australia	Premier Dermatology	Sydney	New South Wales
Australia	Premier Specialists	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Premier Specialists, Australia	The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KP-IGA	KP-IGA is a standard 0-4 IGA score.	through study completion, an average of 1 year
Primary	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
Primary	Likert Scale of Magnitude of CHange	15-point Likert scale from -7 (deterioration) to +7 (improvement)	through study completion, an average of 1 year
Primary	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