Keratosis PilarisNCT06032078
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris
A study testing Cutera laser machine in people with Keratosis Pilaris, run by Premier Specialists, Australia at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratosis Pilaris
- What is being tested?
- Cutera laser machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesAustralia
- Study dates
- 26 Jul 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Premier Dermatology
Sydney, New South Wales, 2217
Premier Specialists
Sydney, New South Wales, 2217
About this study
Official title: Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis
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.
Read the 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.
- Conditions
- Keratosis Pilaris
- Being tested
- Cutera laser machine
- Keywords
- responsiveness, investigator global assessment
- Medical subject headings
- Burnett Schwartz Berberian syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutera laser machineDevice
1064nm Nd: YAG laser
| Study group | Role | What they receive |
|---|---|---|
| Patients with keratosis pilaris | Experimental | Patients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline. Receives: Device: Cutera laser machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
KP-IGA
KP-IGA is a standard 0-4 IGA score.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Likert Scale of Magnitude of CHange
15-point Likert scale from -7 (deterioration) to +7 (improvement)
Measured: through study completion, an average of 1 year
Physician's Global Assessment
10-point scale form 0 to 10 showing the worst skin condition to the best
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start26 Jul 2023
- Primary completion29 Dec 2023 (estimated)
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratosis PilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 15 patients with keratosis pilaris (including subtypes) are recruited
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Premier Specialists, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Principal investigator, Dedee Murrell, Premier Specialists, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032078
- Sponsor's protocol ID
- 2022-04-376-A-3
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis
- ClinicalTrials.gov ID
- NCT06032078
- Acronym / sponsor ID
- 2022-04-376-A-3
- Conditions
- Keratosis Pilaris
- Keywords
- responsiveness, investigator global assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Premier Specialists, AustraliaUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 29 Dec 2023 (estimated)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 15 patients with keratosis pilaris (including subtypes) are recruited
| Arm | Type | Receives |
|---|---|---|
| Patients with keratosis pilaris | Experimental | Device: Cutera laser machinePatients treated with 3 sessions of 1064nm Nd: YAG laser at 4-weekly intervals. Results are compared with baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cutera laser machine1064nm Nd: YAG laser | Device | Patients with keratosis pilaris |
Primary outcome
KP-IGA
Time frame: through study completion, an average of 1 year
KP-IGA is a standard 0-4 IGA score.
KPAI
Time frame: 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.
Likert Scale of Magnitude of CHange
Time frame: through study completion, an average of 1 year
15-point Likert scale from -7 (deterioration) to +7 (improvement)
Physician's Global Assessment
Time frame: through study completion, an average of 1 year
10-point scale form 0 to 10 showing the worst skin condition to the best
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No. 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.
Related trials for Keratosis Pilaris
Recruiting
Investigating the Safety and Efficacy of the 1927-nm Thulium Laser in Keratosis Pilaris
Keratosis Pilaris (KP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cutera laser machine in people with Keratosis Pilaris, run by Premier Specialists, Australia at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KP-IGA (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.