Clinical trial · Interventional
Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV
Exploratory, Randomized, Multicenter, Open-Label, Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy of Papilozumib® Vaginal Gel in the Restoration of the Exocervical Mucosa
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, open-label, multicenter clinical study is designed to evaluate Papilozumib® vaginal gel in women aged 30 to 50 years who test positive for human papillomavirus (HPV) and present with either normal cervical cytology or cytological findings of atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), accompanied by corresponding colposcopic findings. Eighty-one participants will be randomly assigned in equal groups to receive either Papilozumib® vaginal gel, Papilozumib® vaginal gel plus an oral supplement, or standard clinical care without study treatment. All participants will be followed for six months. The primary objective is to assess exocervical mucosa restoration 30 days after treatment initiation using a 5-point colposcopic scale. Additional assessments include cervical cytology, HPV clearance, vaginal health, treatment adherence, satisfaction, tolerability, safety, and exploratory analyses of the vaginal and intestinal microbiota.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Human Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Papilozumib oral supplement | Dietary Supplement | — | UNRESOLVED |
| Papilozumib vaginal gel | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Papilozumib vaginal gel
- description
- Participants receive Papilozumib® vaginal gel for 6 months. During the first 3 months, one single-dose vaginal applicator is administered daily for 21 days followed by 7 days without treatment. During the following 3 months, one applicator is administered on alternate days, excluding menstrual periods
- interventionNames
- Device: Papilozumib vaginal gel
- type
- EXPERIMENTAL
- label
- Papilozumib vaginal gel plus oral supplement
- description
- Participants receive Papilozumib® vaginal gel for 6 months using the same regimen as the vaginal-gel-only arm. Participants also receive oral Papilozumib® for 6 months, administered as two capsules while fasting and one capsule before dinner each day, separated from meals.
- interventionNames
- Device: Papilozumib vaginal gel
- Dietary Supplement: Papilozumib oral supplement
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Female participant aged 30 to 50 years, inclusive. * Able to read and understand the participant information sheet and informed consent form. * Willing to participate and able to provide written informed consent. * Normal cervical cytology or cervical cytology showing atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), with corresponding colposcopic findings at baseline. * Cervical cytology obtained no more than 3 months before the baseline/randomization visit. * Positive test for human papillomavirus (HPV) by polymerase chain reaction (PCR) at baseline. * HPV PCR test obtained no more than 3 months before the baseline/randomization visit. * Exocervical mucosal restoration score of 3 or lower on the 5-point colposcopic scale at baseline. * Baseline colposcopy performed no more than 3 months before randomization; the score may be determined from previously recorded images when available in the medical record. * Considered by the investigator able to follow the study instructions, attend the required visits, and complete the study assessments. Exclusion Criteria: * Clinically relevant immune-system disorder, autoimmune disease, or current treatment with immunosuppressive medication. * Systemic or local treatment with antibiotics, antifungal agents, or another treatment that may alter the microbiota within 4 weeks before baseline/randomization. * Undiagnosed abnormal genital bleeding during the 6 months before screening. * Symptomatic vulvovaginal infection. * Surgical cervical excision within the previous year, cervical conization within the previous 6 months, or previous total hysterectomy. * Previous gynecological cancer. * Current participation in another clinical study or participation in another clinical study within 4 weeks before screening. * Planned surgery that could prevent adherence to the study treatment schedule. * Use of vaginal contraceptives or other vaginal hormonal treatments. * Contraindication to the vaginal gel or known allergy to any of its components. * Pregnant, suspected to be pregnant, breastfeeding, or of childbearing potential and not using an effective contraceptive method.
References
Publications (0)
Data not yet available