Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris (NCT06032078) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of the Responsiveness of Investigator Global Assessment Score for Keratosis Pilaris
Australia15 participantsStarted 2023-07-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
KP-IGA
Timeframe: through study completion, an average of 1 year
2
KPAI
Timeframe: through study completion, an average of 1 year
3
Likert Scale of Magnitude of CHange
Timeframe: through study completion, an average of 1 year
4
Physician's Global Assessment
Timeframe: through study completion, an average of 1 year