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

• Sponsor: Premier Specialists, Australia (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06032078
• Collaborator: The University of New South Wales (Other)
• Enrollment: 15
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 5.1
• Patients Per Site: 7.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratosis Pilaris	Device: Cutera laser machine	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 15 patients with keratosis pilaris (including subtypes) are recruited15 patients with keratosis pilaris (including subtypes) are recruited
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis
• Actual Study Start Date: Jul 26, 2023
• Anticipated Primary Completion Date: Dec 29, 2023
• Anticipated Study Completion Date: Dec 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with keratosis pilaris Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline.	Device: Cutera laser machine; 1064nm Nd: YAG laser

Outcome Measures

Primary Outcome Measures

1. KP-IGA [through study completion, an average of 1 year]

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

2. KPAI [through study completion, an average of 1 year]

   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.

3. Likert Scale of Magnitude of CHange [through study completion, an average of 1 year]

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

4. Physician's Global Assessment [through study completion, an average of 1 year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Premier Dermatology	Sydney	New South Wales	Australia	2217
2	Premier Specialists	Sydney	New South Wales	Australia	2217

Sponsors and Collaborators

• Premier Specialists, Australia
• The University of New South Wales

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dedee Murrell, Professor Dedee Murrell, Premier Specialists, Australia
• ClinicalTrials.gov Identifier: NCT06032078
• Other Study ID Numbers: 2022-04-376-A-3
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dedee Murrell, Professor Dedee Murrell, Premier Specialists, Australia: responsiveness; investigator global assessment
• Additional relevant MeSH terms: Keratosis, Actinic; Keratosis

Study Results

No Results Posted as of Sep 11, 2023