Papillex® for Cervical Dysplasia

Overseen By Erin Lewis, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Papillex Inc.

Must not be taking: OTC medications, Supplements

Disqualifiers: Pregnancy, Cervical cancer, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

60 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

David Crowley, MD

Principal Investigator

KGK Science Inc.

Eligibility Criteria

This trial is for women with abnormal cervical cells due to HPV, specifically those diagnosed with CIN 1 or 2. Participants will take Papillex® or a placebo for six months and undergo tests like PAP smears, HPV testing, and possibly a colonoscopy.

Inclusion Criteria

Provided voluntary, written, informed consent to participate in the study

Willing to provide copies of pathology and cytology reports for eligibility confirmation

Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include hormonal contraceptives, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomized partner, abstinence

Exclusion Criteria

Self-reported confirmation of blood/bleeding disorders as assessed by the QI

Individuals with an autoimmune disease or are immune compromised

Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable)

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term from day 180 to day 360

26 weeks

Treatment Details

Interventions

• Papillex®

Trial Overview The study is testing the safety and effectiveness of Papillex®, compared to a placebo, in helping regress abnormal cervical cells caused by HPV. The main focus is whether there's an improvement from the start of the trial after taking Papillex® for 180 days.

Participant Groups

Group I: Placebo Experimental Treatment 1 Intervention

Group II: Papillex® Experimental Treatment 1 Intervention

The investigational product, Papillex®, is a dietary supplement containing vitamins B12, C, and E, mixed carotenoids, folate, zinc, selenium, green tea leaf extract, broccoli sprout powder, astragalus, natural all-trans-lycopene and reishi mushroom extracts

Who Is Running the Clinical Trial?

Papillex Inc.

Lead Sponsor