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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06032078




Registration number
NCT06032078
Ethics application status
Date submitted
28/08/2023
Date registered
11/09/2023

Titles & IDs
Public title
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris
Scientific title
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis
Secondary ID [1] 0 0
2022-04-376-A-3
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Keratosis Pilaris 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cutera laser machine

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


Treatment: Devices: Cutera laser machine
1064nm Nd: YAG laser
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
KP-IGA
Timepoint [1] 0 0
through study completion, an average of 1 year
Primary outcome [2] 0 0
KPAI
Timepoint [2] 0 0
through study completion, an average of 1 year
Primary outcome [3] 0 0
Likert Scale of Magnitude of CHange
Timepoint [3] 0 0
through study completion, an average of 1 year
Primary outcome [4] 0 0
Physician's Global Assessment
Timepoint [4] 0 0
through study completion, an average of 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Premier Dermatology - Sydney
Recruitment hospital [2] 0 0
Premier Specialists - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Premier Specialists, Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data obtained will be stored securely on-site premises and will not be articulated outside of Australia. Data obtained from patients through scoring sheets and QOL questionnaires will be transcribed as de-identifiable data in an Excel spreadsheet into a password-protected computer (only the investigators with the corresponding study codes given to each patient can identify the data for the purpose of study data analysis). The original scoring sheets and QOL questionnaires will be stored securely on-site and may only be accessed by investigators and co-investigators, as detailed in the patient consent form.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06032078