Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With HPV

NCT07762209 | Not Yet Recruiting

• 1 other identifier: HIFAS 2024-001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 6

Brief Summary

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

Human Papillomavirus Infection; Human Papillomavirus Infections

Keywords

Human Papillomavirus; HPV; Exocervical Mucosal Restoration; Cervical Cytology; ASC-US; Low-Grade Squamous Intraepithelial Lesion; LSIL; Atypical Glandular Cells; AGC; HPV Clearance; Vaginal Health; Vaginal Microbiota; Gut Microbiota; Papilozumib; Vaginal Gel

Outcome Measures

Primary Outcomes (2)

• Exocervical mucosal restoration score at Day 30

  Exocervical mucosal restoration will be assessed by colposcopy in participants assigned to Papilozumib® vaginal gel alone. The investigator will score the exocervical mucosa using a 5-point scale: 1, severe ectopia with bleeding; 2, severe or extensive ectopia involving more than 50% from the external cervical opening; 3, moderate ectopia involving 25% to 50%; 4, mild ectopia involving less than 25%; and 5, no ectopia. Higher scores indicate greater exocervical mucosal restoration.

  Day 30 after treatment initiation

• Participants with concordant cytology and colposcopy at Day 30

  In participants assigned to Papilozumib® vaginal gel alone, the investigator will record whether the cervical cytology result is concordant with the colposcopic finding using a "Yes" or "No" response. The outcome will be reported as the percentage of participants with concordant findings.

  Day 30 after treatment initiation

Secondary Outcomes (11)

• Exocervical mucosal restoration score at follow-up visits

  Day 30 for Arms B and C; Month 3 and Month 6 for all arms

• Percentage of participants with concordant cytology and colposcopy findings

  Day 30 for Arms B and C; Month 3 and Month 6 for all arms

• Percentage of participants with normalization of abnormal cervical cytology

  Day 30, Month 3, and Month 6

• Percentage of participants with complete Human Papillomavirus Virus clearance

  Month 6

• Percentage of participants with partial Human Papillomavirus Virus clearance

  Month 6

Other Outcomes (2)

• Vaginal microbiota community state type

  Baseline and Month 6

• Intestinal microbiota Shannon diversity index

  Baseline, Month 3, and Month 6

Study Arms (3)

Papilozumib vaginal gel

EXPERIMENTAL

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

Device: Papilozumib vaginal gel

Papilozumib vaginal gel plus oral supplement

EXPERIMENTAL

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.

Device: Papilozumib vaginal gel; Dietary Supplement: Papilozumib oral supplement

Usual clinical practice without study treatment

NO INTERVENTION

Participants receive usual clinical practice without Papilozumib® vaginal gel or oral Papilozumib® supplementation. Participants undergo the study assessments and follow-up procedures specified in the protocol.

Interventions

Papilozumib vaginal gel DEVICE

Papilozumib® is a single-dose vaginal gel administered for 6 months. During the first 3 months, participants apply one vaginal applicator daily for 21 days followed by 7 days without treatment. During the following 3 months, participants apply one applicator on alternate days, excluding menstrual periods.

Papilozumib vaginal gel; Papilozumib vaginal gel plus oral supplement

Papilozumib oral supplement DIETARY_SUPPLEMENT

Papilozumib® oral supplement is provided as capsules containing mushroom extracts, vitamins, minerals, and probiotics. Participants take three capsules daily for 6 months: two capsules while fasting and one capsule before dinner, separated from meals.

Papilozumib vaginal gel plus oral supplement

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hifas da Terra S.L.: lead
• Adknoma Health Research: collaborator
• Eurofins: collaborator

Study Sites (6)

Hospital HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

Ginegetafe

Getafe, Madrid, 28901, Spain

Location

Hospital Universitario Sanitas La Moraleja - Edificio Ana de Austria

Hortaleza, Madrid, 28050, Spain

Location

Instituto Palacios, Salud y Medicina de la Mujer

Madrid, Madrid, 28009, Spain

Location

Consulta Privada Miguel Ángel Rodríguez Zambrano

Majadahonda, Madrid, 28220, Spain

Location

Hospital Quirónsalud Valle del Henares

Torrejón de Ardoz, Madrid, 28850, Spain

Location

MeSH Terms

Conditions

Papillomavirus Infections; Atypical Squamous Cells of the Cervix; Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Cervical Dysplasia; Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Morphological and Microscopic Findings

Central Study Contacts

Mayte Monreal Núñez

CONTACT

+34 637 551 110; mayte.monreal@hifashub.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized in a 1:1:1 ratio to one of three parallel groups: Papilozumib® vaginal gel, Papilozumib® vaginal gel plus oral Papilozumib® supplement, or usual clinical practice without study treatment. Randomization is stratified by study center using permuted blocks of three.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6)