Actively Recruiting
A Randomized, Triple-blind, Placebo-controlled Trial to Investigate the Safety and Efficacy of Papillex4 on Abnormal Cervical Cells Caused by HPV
Led by Papillex Inc. · Updated on 2026-03-05
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of Papillex4, a dietary supplement, on the regression of abnormal cervical cells caused by HPV in women diagnosed with cervical intraepithelial neoplasia CIN grades 1 or 2. The main goal is to see if Papillex4 leads to a greater improvement in cervical cell abnormalities compared to a placebo by day 180. Participants will take either Papillex4 or a placebo twice daily for 180 days. Papillex4 contains vitamins, minerals, plant extracts, and other natural substances. Both groups will follow the same dosing schedule with two capsules taken with the first and last meals each day. The study design is randomized and quadruple-blinded, meaning neither participants nor researchers know who receives Papillex4 or placebo. During the study, participants will undergo clinical visits, complete questionnaires, and have cervical cell assessments including PAP smears and HPV tests. Some may have colonoscopy if applicable. Researchers will measure changes in cervical cell abnormalities, HPV clearance, immune markers, micronutrient status, symptom scores, quality of life, and monitor safety events over 180 to 360 days. Participants are expected to maintain their usual lifestyle habits and complete all study activities and visits.
CONDITIONS
Brief Title
A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female between 25 and 55 years old
- Females not of child-bearing potential or those of child-bearing potential with a negative pregnancy test and agreement to use approved birth control
- Histologically confirmed CIN1+ with hrHPV positivity and current abnormal cytology and hrHPV positivity at screening
- Willing to provide histology and/or cytology reports for eligibility
- Agree to maintain current lifestyle habits during the study
- Willing to avoid certain imaging procedures 48 hours before micronutrient assessments
- Able and willing to complete questionnaires, diaries, clinic visits, and assessments
- Provided written informed consent
- Otherwise healthy as determined by medical history and lab results
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance to ingredients of the investigational product or placebo
- Current or recent treatment for CIN or active CIN 3
- Concurrent uterine pathologies
- History of hysterectomy or destructive cervical therapy
- Cervical cancer
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension or recent significant cardiovascular events
- Kidney or liver diseases except symptom-free kidney stones
- Thyroid conditions unless stable on medication
- Recent major surgery or planned surgery during study
- History of cancer except certain skin cancers or remission over 5 years
- Autoimmune diseases or immune compromise
- HIV, Hepatitis B or C, or blood/bleeding disorders
- High alcohol intake or recent substance abuse
- Use of medications or supplements that may affect investigational product
- Abnormal lab results at screening
- Blood donation or participation in other clinical studies near baseline
- Cognitive impairment or inability to consent
- Any other factor posing risk or affecting study completion as judged by investigator
Research Team
E
Erin Lewis, PhD
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