The goal of this clinical trial is to learn if an investigational vaginal suppository therapy works to treat low-grade cervical lesions (ASC-US and LSIL) associated with high-risk human papillomavirus (hr-HPV) infection in women. It will also learn about the safety and tolerability of this investigational therapy. The main questions it aims to answer are:
* Does the investigational therapy lead to regression of cervical lesions? * Does the investigational therapy help clear hr-HPV infection? * Do any adverse effects occur from using this medical product?
Researchers will compare the investigational therapy to a placebo (a look-alike substance that contains no active drug) to see if the investigational therapy works.
Participants will:
* Be screened for hr-HPV, cervical abnormalities, and other conditions to be assessed for eligibility * Self-administer 15 doses of the investigational therapy or placebo as a vaginal suppository over 19 calendar days * Attend scheduled clinic visits for examinations, testing, and monitoring for a period of two months * Undergo assessments to evaluate cervical lesion status, hr-HPV infection, and safety outcomes * Keep a daily diary of investigational therapy use and associated information
Participants capable of giving informed consent
Females, ages 18 to 65 years old at the time of signature of the informed consent form.
Participants who are able to correctly self-administer the intravaginal suppositories
One or more hr-HPV oncotypes as confirmed by HPV test
Presence of HSIL at screening cytology
Evidence of glandular abnormalities (AGC/AIS) at screening cytology
BMI below 16
Pregnant or nursing females
Parallel
EGCG and Quinine Sulfate Vaginal Suppository
DrugEpigallocatechin gallate + Quinine Sulfate - Dysplasix™ Semisolid Intravaginal suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.
Placebo
Other interventionSemisolid Intravaginal Suppository 15 doses administered over the span of 3 x 5 consecutive nightly administration of investigational therapy, followed by a two day pause between cycles for a total of 15 doses administered over 19 calendar days. If menses occurs during treatment, investigational product use should be suspended until menses seizes and continued thereafter until 15 doses have been administered.
To determine and evaluate the safety and tolerability of Dysplasix™ intravaginal suppository therapy in females with hr-HPV and positive cytology for either ASCUS or LSIL.
Number of participants with serious adverse events (SAEs) or dose-limiting toxicities (DLTs) related to the study intervention assessed using relevant Common Terminology Criteria for Adverse Events (CTCAE).
Regression of cervical cytology present at study entry
Participants whose baseline Atypical Cells of Undetermined Significance (ASCUS) or Low-Grade Squamous Intraepithelial Lesions (LSIL) regress to Normal for Intraepithelial Lesions or Malignancies (NILM), 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by cytology
Clearance of hr-HPV genotype present at study entry
Participants whose high-risk human papillomavirus (HPV) genotypes present at study entry become undetectable 30 days after completion of 15-day course of Dysplasix™ therapy (3 x 5-day cycles), as assessed by HPV testing
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Amplexd Therapeutics, Inc.
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
Chinese University of Hong Kong
Collaborator
