A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-55
SponsorPapillex Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Females between 25 and 55 years of age
Females not of child-bearing potential, defined as those who have undergone a permanent sterilization procedure (e.g. hysterectomy, bilateral oophorectomy or bilateral tubal occlusion) or have been post-menopausal for at least 1 year prior to screening Or,
Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), hormone implant (Norplant System) or intrauterine hormone-releasing system
Double-barrier method
Disqualifiers
Women who are pregnant, breast feeding, or planning to become pregnant during the study
Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients
Currently undergoing treatment for CIN, are indicated for treatment during the study period, have received treatment (e.g., conization or loop electrosurgical excision procedure) within the last five years, or have active CIN 3
Concurrent uterine pathologies
Trial design
Design model
Parallel
Treatments tested in this trial
Papillex®
Dietary supplementParticipants 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.
Placebo
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Papillex®Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 180 between Papillex® and placebo.
Time frame
Day 0 to 180Secondary outcomes
1
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 3602
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 3603
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 1804
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 360Other outcomes
1
Clinically relevant changes in blood pressure after supplementation
Clinically relevant changes in blood pressure after supplementation at Day 180
Time frame
Day 0 to 1802
Clinically relevant changes in heart rate after supplementation
Clinically relevant changes in heart rate after supplementation at Day 180
Time frame
Day 0 to 1803
Clinically relevant changes in clinical chemistry after supplementation at Day 180
Time frame
From enrollment to Day 1804
Clinically relevant changes in complete blood count after supplementation at Day 180
Time frame
Day 0 to 180Sponsors and contacts
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Source ClinicalTrials.gov