The goal of this clinical trial is to investigate the safety and efficacy of Papillex® on the regression of abnormal cervical cells caused by HPV in women with a cervical intraepithelial neoplasia (CIN) 1 or 2 diagnosis. The main question it aims to answer is: Is there a difference in the proportion of participants with a regression in CIN based on histology or cytology from baseline at day 180 between Papillex® and placebo? Participants will be asked to consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.
Participants will be instructed to take two capsules twice daily with food, with the first dose taken with the first meal of the day and the second dose taken with the last meal of the day.
KGK Science Inc.
London, Ontario, Canada
RECRUITINGThe difference in the proportion of participants with cytology improvement
The difference in the proportion of participants with cytology improvement defined as improvement by ≥1 Bethesda category on Pap smear (e.g., HSIL→LSIL/NILM; LSIL→NILM) from baseline at day 180 between Papillex® and placebo.
Time frame: Day 0 to 180
The difference in the proportion of participants with cytology improvement
The difference in the proportion of participants with cytology improvement defined as improvement by ≥1 Bethesda category on Pap smear (e.g., HSIL→LSIL/NILM; LSIL→NILM) from baseline at day 360 between Papillex® and placebo.
Time frame: Day 0 to 360
The difference in the proportion of participants with genotype-specific HPV clearance,
The difference in the proportion of participants with genotype-specific HPV clearance, defined as negative for the genotypes present at baseline, at day 360 between Papillex® and placebo
Time frame: Day 0 to 360
Change in immune markers (T lymphocytes, interferon (IFN)-β) between Papillex® and placebo
Change in immune markers (T lymphocytes, interferon (IFN)-β) from baseline to day 180 between Papillex® and placebo
Time frame: Day 0 to 180
The difference in the proportion of responders
The difference in the proportion of responders, defined as cytology improvement at day 180 OR genotype-specific HPV clearance at day 360
Time frame: Day 0 to 180, or 360
The difference in the proportion of deep responders
The difference in the proportion of deep responders, defined as cytology improvement at day 180 AND genotype specific HPV clearance at day 360, between Papillex® and placebo
Time frame: Day 0 to 180 and 360
Concordance between cytology and histology results (where performed as standard of care)*
Concordance between cytology and histology results (where performed as standard of care)\*. \*For participants who elect to provide colposcopy reports at screening/baseline and during/following completion of the clinical trial (minimum of n = 20; n = 10/group)
Time frame: Day 0 to 360
Change in micronutrient status
Change in micronutrient status from baseline to day 180 between Papillex and placebo as assessed by blood concentrations of vitamin B12, folate (vitamin B9), zinc, and selenium.
Time frame: Day 0 to 180
Change in Symptoms Checklist score between Papillex® and placebo
Change in Symptoms Checklist score from baseline to days 180 between Papillex® and placebo
Time frame: Day 0 to 180
Change in Symptoms Checklist score between Papillex® and placebo
Change in Symptoms Checklist score from baseline to days 360 between Papillex® and placebo
Time frame: Day 0 to 360
Change in SF-36 Quality of Life (QoL) score between Papillex® and placebo
Change in SF-36 Quality of Life (QoL) score from baseline to days 180 between Papillex® and placebo
Time frame: Day 0 to 180
Change in SF-36 Quality of Life (QoL) score between Papillex® and placebo
Change in SF-36 Quality of Life (QoL) score from baseline to days 360 between Papillex® and placebo
Time frame: Day 0 to 360
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Time frame: Day 0 to 360
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