Dysplasix™ intravaginal suppositories for women with high‑risk HPV and mild cervical cell changes
A Phase II, Randomized, Double-blind, Placebo-Controlled, Proof of Concept Study to Assess the Safety and Efficacy of Dysplasix™ Intravaginally-Administered Suppositories in Patients With High-Risk Human Papillomavirus (Hr-HPV) as Determined by HPV Testing, and Accompanied by Either (1) Atypical Squamous Cells of Undetermined Significance (ASC-US) or (2) Low-Grade Squamous Intraepithelial Lesions (LSIL), as Determined by Cytology
This trial tests whether nightly Dysplasix™ vaginal suppositories can clear high‑risk HPV and help mild cervical cell changes (ASC‑US or LSIL) in adult women.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Amplexd Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Shatin, New Territories) |
| Trial ID | NCT07572396 on ClinicalTrials.gov |
What this trial studies
This Phase II, double‑blind, randomized, placebo‑controlled study enrolls women with high‑risk HPV and cytology showing ASC‑US or LSIL. Enrolled participants self‑administer an intravaginal suppository nightly across a fifteen‑day course (three 5‑day cycles with two days off) and are randomized 1:1 to Dysplasix™ (EGCG + quinine sulfate) or matching placebo. Primary outcomes include regression of cervical cytologic abnormalities and clearance of hr‑HPV measured about 30 days after treatment, while safety and tolerability are tracked with participant diaries and clinic visits. Key exclusions include the presence of high‑grade lesions or glandular abnormalities, and participants must be able to attend clinic visits at the enrolling center.
Who should consider this trial
Good fit: Women aged 18–65 who are immune‑competent, test positive for high‑risk HPV, have ASC‑US or LSIL cytology, can self‑administer vaginal suppositories, and can attend follow‑up visits are the intended participants.
Not a fit: Patients with high‑grade cervical lesions (HSIL), glandular abnormalities, immune compromise, or those unable to use contraception or attend clinic visits are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could clear hr‑HPV and reverse low‑grade cervical lesions, potentially reducing the need for invasive follow‑up procedures.
How similar studies have performed: Topical EGCG preparations have shown some promising results in small studies for HPV‑related lesions, but intravaginal EGCG combined with quinine sulfate is a novel approach that has not been widely tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must meet all the following criteria to be eligible to enroll in the study: 1. Participants capable of giving informed consent 2. Females, ages 18 to 65 years old at the time of signature of the informed consent form. 3. Participants who are able to correctly self-administer the intravaginal suppositories 4. One or more hr-HPV oncotypes as confirmed by HPV test 5. Participants with ASCUS or LSIL abnormalities as confirmed by cytology 6. Immune competent 7. Participants of childbearing potential must have a negative pregnancy test at screening. 8. Participants of childbearing potential must agree to use appropriate contraception or abstain from sexual intercourse for the duration of the study 9. Participants must not have received a recent HPV vaccination and must abstain from HPV vaccination until the end of study Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Presence of HSIL at screening cytology 2. Evidence of glandular abnormalities (AGC/AIS) at screening cytology 3. BMI below 16 4. Pregnant or nursing females 5. Evidence of vaginal/vulval comorbidities, specifically, common sexually transmitted or vaginal infections, and bloodborne pathogens 7\. Using a vaginal contraceptive ring 8\. History of irregular menstrual cycles or routine intermenstrual bleeding 9\. Active autoimmune disease 10\. Taking prohibited concomitant medications 11\. Concurrent malignancy except for non-melanoma skin lesions 12\. Active participation in another clinical trial involving therapeutic intervention (unless ending within 30 days of screening date)
Where this trial is running
Shatin, New Territories
- Prince of Wales Hospital — Shatin, New Territories, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kar Kei Yung, MBBS (HK), MRCOG, FHKCOG, FHKA — Prince of Wales Hospital, Chinese University of Hong Kong
- Study coordinator: Trial Manager
- Email: p2trialhk@amplexd.com
- Phone: 713-933-9640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.