Actinic keratosis (AK), also known as solar keratosis, is a common skin condition characterised by abnormal growth of skin cells caused by long-term sun exposure. AK is considered to be a precancerous lesion, and is therefore commonly treated to reduce the risk of malignant transformation into skin cancer. The trial is a randomised, double-blind, vehicle-controlled, dose-comparison trial in which adult subjects with AK grade 1 or 2 will be treated with AVX001 silicone-based gel in doses of 1% or 3% or with a gel vehicle for a 4-week field-directed treatment period. Subjects will be followed up for 8 weeks after the treatment period. The primary objective is to evaluate the local tolerability of daily applications of AVX001 gel in doses of 1% or 3% and compare with vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Topical gel treatment for once daily application
Bispebjerg Hospital
Copenhagen, Region Sjælland, Denmark
Proportion of subjects with local skin reaction (LSR) >2
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on frequency of SAEs
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on frequency of AEs
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on skin examinations
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on blood pressure (vital sign)
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on pulse (vital sign)
Time frame: Baseline to end of study (12 weeks)
Assessment of safety based on temperature (vital sign)
Time frame: Baseline to end of study (12 weeks)
Proportion of subjects who experience LSR grade 1, 2, 3 and 4
Time frame: Baseline to End of Treatment and End of Study (week 4)
Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic
Time frame: Baseline to the end of treatment visit (EOT) (week 4) / early termination.
Proportion of subjects experiencing a clinically visible clearance of target area of >50% as assessed in-clinic
Time frame: Baseline to the end of the study visit (EOS, week 12).
Recurrence rate of AKs as assessed in-clinic after treatment clearance
Time frame: Between End of Treatment (week 4) and End of Study visits (week 12).
Appearance of new lesions in the target area as assessed in-clinic
Time frame: From Baseline to EOS (week 12)
Subject satisfaction with the AVX001 gel, assessed by TSQM
Time frame: at Week 2 and EOT (week 4).
Proportion of patients with a cosmetic outcome grade <2 , as assessed using the Cosmetic Scoring Tool.
Time frame: from Baseline to EOS (week 12)
Cosmetic outcome of target area as evaluated by participants by comparing the status at EOS with a baseline photo
Time frame: Baseline and End of Study (week 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.