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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Papillex®, a dietary supplement, can reduce abnormal cervical cells in women with early-stage cervical changes, known as cervical intraepithelial neoplasia (CIN), caused by HPV. Participants will take either Papillex® or a placebo for 180 days to assess any differences in cell improvement. Women diagnosed with CIN 1 or 2 and who have tested positive for HPV are suitable candidates for this study. As an unphased trial, it provides an opportunity to contribute to understanding potential non-invasive treatments for cervical health.

Do I have to stop taking my current medications for the trial?

The trial requires participants to maintain their current lifestyle habits, including medications, as much as possible throughout the study. However, if you are taking medications that might impact the safety or effectiveness of the trial product, you may need to stop or adjust them, as assessed by the study's Qualified Investigator.

Is there any evidence suggesting that Papillex® is likely to be safe for humans?

Research on Papillex® hasn't yet provided clear information about its safety, but a few points can be considered. Papillex® is a dietary supplement composed of vitamins and natural extracts, which are generally considered safe for everyday use. It is not a new drug but a mix of well-known nutrients and herbal extracts.

The trial phase is labeled as "Not Applicable," indicating that Papillex® might not have undergone the same rigorous testing as new drugs. However, its ingredients, such as vitamins B12, C, and E, and minerals like zinc and selenium, are commonly found in dietary supplements and are usually safe for most people. No reports of serious side effects from these ingredients exist.

While this doesn't replace detailed safety data from clinical trials, knowing that the ingredients are generally safe for regular use is helpful. Participants should feel reassured by this, but it's always important to consult healthcare providers before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Papillex® is unique because it combines a mix of natural ingredients, including vitamins B12, C, and E, carotenoids, folate, zinc, selenium, and plant extracts like green tea, broccoli sprout, astragalus, and reishi mushroom. Unlike standard treatments for cervical dysplasia, which often involve surgical procedures or topical medications, Papillex® offers a non-invasive dietary supplement approach. Researchers are excited about its potential to provide a natural, holistic method for supporting cervical health, which could complement or even reduce the need for more invasive treatments.

What evidence suggests that Papillex® might be an effective treatment for cervical dysplasia?

This trial will compare Papillex® with a placebo. Studies have shown that some ingredients in Papillex®, such as vitamins and plant extracts, support immune health and might help the body fight HPV. Research indicates that ingredients like green tea extract and reishi mushroom may reduce abnormal cell growth. Early findings suggest that vitamin C and folate can support cell health and might help abnormal cervical cells return to normal. Although more studies on people are needed, these ingredients are thought to work together to potentially help the body manage changes related to HPV. The scientific community remains hopeful about Papillex®'s potential benefits, but more research is needed to confirm these effects. ^{1 2 3 4 6}

Who Is on the Research Team?

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979180

A Clinical Trial to Investigate the Safety and Efficacy of ... 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 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/b8c6d3c950195416/nct06979180-papillex-hpv-cervical-cells

A Clinical Trial to Investigate the Safety and Efficacy of ... 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 ...

3. ctv.veeva.com ctv.veeva.com/study/a-clinical-trial-to-investigate-the-safety-and-efficacy-of-papillex-r-on-the-regression-of-abnormal-c

A Clinical Trial to Investigate the Safety and Efficacy of ... 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.

4. withpower.com withpower.com/trial/papillex-for-cervical-dysplasia-47430

Papillex® for Cervical Dysplasia 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.

5. app.trialscreen.org app.trialscreen.org/trials/clinical-to-investigate-safety-efficacy-papillex-on-regression-abnormal-trial-nct06979180

A Clinical Trial to Investigate the Safety and Efficacy of ... Benefits: Participation in this study may contribute to the development of a safe and effective treatment for HPV-related cervical abnormalities. Participants ...

6. papillex.com papillex.com/wp-content/uploads/2024/05/PAPILLEX-Ingredient-ResearchV3.pdf

PAPILLEX-Ingredient-Research (2).numbers The study suggested that zinc deficiency could be associated with an increased risk of cervical dysplasia and highlighted the importance of zinc in cervical ...