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Tolerance and Effectiveness of C14 on HPV Infection

NCT06672653 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-11-04

No results posted yet for this study

Summary

The zinc monoterpenoid tetra-ascorbo-camphorate possesses broad-spectrum anti-viral properties in vitro, particularly against HIV, HSV and HPV. Its C14 formulation could be a promising candidate for in vivo clinical evaluation as a potential microbicide or therapeutic drug.

The aim of this clinical trial is to determine whether C14 is effective in reducing the genital viral load of HR-HPV and in treating low-grade dysplastic lesions of the cervix. It will also determine the tolerability of C14. The main questions to be answered by the clinical trial are as follows:

Does C14 reduce the genital HR-HPV viral load in participants with persistent HR-HPV infections? What medical problems do participants experience when taking C14? Researchers will compare C14 to a placebo (a similar substance that contains no drug) to see if C14 is effective in reducing genital C14 viral load and in treating low-grade dysplastic lesions of the cervix.

Participants will

receive four monthly treatments (5ml of C14 dissolved in distilled water administered twice daily \[morning and evening\] for seven days via vaginal syringe during the follicular phase) of C14 or placebo for 4 months and visit the clinic once every 2 weeks for examinations and tests. They will keep a diary of their symptoms and the number of times they keep the hospital appointment.

Conditions

  • HPV-induced Cancers
  • HPV Infections
  • HIV
  • Cervical Cancers
  • Trial
  • C14
  • Monoterpenoid Zinc Tetra-ascorbo-camphorate

Interventions

DRUG

The monoterpenoid zinc tetra-ascorbo-camphorate ("C14")

The trial phase will consist of hospital administration by vaginal syringe of 5ml of 1% C14, twice a day for 7 days, starting the first cure during the follicular phase of the cycle, just after the last menstrual period (S1), the second cure the following month (S5), the third cure 4 weeks later (S9) and the last cure 8 weeks later (S13). Gynaecological follow-up with HPV molecular testing and cervical smear will be performed two days after each course of treatment at S2, S6, S10, S14 and 2 weeks after the last course of treatment (S16). Unprotected sexual intercourse will not be permitted during each course of treatment, and for at least 72 hours before each genital swab.

DRUG

Distilled water group

Instead of C14, distilled water will be administered in this group.

Sponsors & Collaborators

  • MGB Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-03-15
Completion
2025-07-15

Countries

  • Democratic Republic of the Congo

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06672653 on ClinicalTrials.gov