CIN - Cervical Intraepithelial NeoplasiaNCT06979180
A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
A study testing Papillex® in people with CIN - Cervical Intraepithelial Neoplasia and CIN 1, run by Papillex Inc. at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- CIN - Cervical Intraepithelial Neoplasia, CIN 1, CIN 2
- What is being tested?
- Papillex®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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,
- 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 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
- Intrauterine devices
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- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomized partner, provided that partner is the sole sexual partner and that the vasectomised partner has received medical assessment of the surgical success
- Abstinence
- Histologically confirmed CIN1+ (as per standard of care) with concordant hrHPV positivity at that time, and current abnormal cytology and hrHPV positivity at screening; interval between historical diagnosis and screening must be >6 months OR documented abnormal cytology (LSIL or worse) plus hrHPV positive >6 months prior, and current abnormal cytology with hrHPV positivity at screening
- Willing to provide copies of histology and/or cytology reports for eligibility confirmation
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Willingness to avoid magnetic resonance imaging, computed tomography, X-ray, or other procedures with contrast media injection for 48 hr prior to study visits assessing micronutrient status
- Willingness and ability to complete questionnaires and diaries associated with the study, and to complete all clinic visits and assessments
- Provided voluntary, written, informed consent to participate in the study
- Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)
Who cannot join
- 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
- History of hysterectomy or destructive therapy of the cervix
- Cervical cancer
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- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- 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
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N5Y 5V6
Erin Lewis, PhD, 1-226-242-4551 ext. 248, elewis@kgkscience.com
David Crowley, MD
About this study
Official title: A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV
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).
- Conditions
- CIN - Cervical Intraepithelial Neoplasia, CIN 1, CIN 2, HPV, Cervical Cells
- Being tested
- Papillex®, Placebo
- Keywords
- Cervical intraepithelial neoplasia, HPV, Papillex
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papillex®Dietary supplement
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Papillex® | Experimental | 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 Receives: Dietary Supplement: Papillex® |
| Placebo | Experimental | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to 180
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 0 to 360
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Measured: Day 0 to 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIN - Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papillex Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979180
- Sponsor's protocol ID
- 24PXCFP01
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV
- ClinicalTrials.gov ID
- NCT06979180
- Acronym / sponsor ID
- 24PXCFP01
- Conditions
- CIN - Cervical Intraepithelial Neoplasia, CIN 1, CIN 2, HPV, Cervical Cells
- Keywords
- Cervical intraepithelial neoplasia, HPV, Papillex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Papillex Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papillex® | Experimental | Dietary Supplement: Papillex®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 |
| Placebo | Experimental | Other: Placebo |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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,
- 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:
- Histologically confirmed CIN1+ (as per standard of care) with concordant hrHPV positivity at that time, and current abnormal cytology and hrHPV positivity at screening; interval between historical diagnosis and screening must be >6 months OR documented abnormal cytology (LSIL or worse) plus hrHPV positive >6 months prior, and current abnormal cytology with hrHPV positivity at screening
- Willing to provide copies of histology and/or cytology reports for eligibility confirmation
Key exclusion criteria (25 listed)
- 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
- History of hysterectomy or destructive therapy of the cervix
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Papillex®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. | Dietary supplement | Papillex® |
| PlaceboParticipants 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. | Other | Placebo |
Primary outcome
The difference in the proportion of participants with cytology improvement
Time frame: Day 0 to 180
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.
12 secondary outcomes
The difference in the proportion of participants with cytology improvement
Time frame: Day 0 to 360
The difference in the proportion of participants with genotype-specific HPV clearance,
Time frame: Day 0 to 360
Change in immune markers (T lymphocytes, interferon (IFN)-β) between Papillex® and placebo
Time frame: Day 0 to 180
The difference in the proportion of responders
Time frame: Day 0 to 180, or 360
The difference in the proportion of deep responders
Time frame: Day 0 to 180 and 360
Concordance between cytology and histology results (where performed as standard of care)*
Time frame: Day 0 to 360
Change in micronutrient status
Time frame: Day 0 to 180
Change in Symptoms Checklist score between Papillex® and placebo
Time frame: Day 0 to 180
Change in Symptoms Checklist score between Papillex® and placebo
Time frame: Day 0 to 360
Change in SF-36 Quality of Life (QoL) score between Papillex® and placebo
Time frame: Day 0 to 180
Change in SF-36 Quality of Life (QoL) score between Papillex® and placebo
Time frame: Day 0 to 360
Incidence of post-emergent adverse events (AE)
Time frame: Day 0 to 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Papillex® in people with CIN - Cervical Intraepithelial Neoplasia and CIN 1, run by Papillex Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the proportion of participants with cytology improvement (time frame: Day 0 to 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.