Clinical trial · Interventional
Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)
A Randomized Controlled Trial to Evaluate the Efficacy of a Dual-Modality Immunotherapy (Oral Immunomodulator and Vaginal Ovule) for Human Papillomavirus (HPV) Clearance
- 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)
Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Low-Grade Squamous Intraepithelial Lesions | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Immunomodulator | Drug | — | UNRESOLVED |
| Standard Supportive Care | Other | — | UNRESOLVED |
| Vaginal Ovule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dual-Modality Immunotherapy
- description
- Participants receive an oral immunomodulator twice daily together with a vaginal ovule administered for 14 consecutive days each month for 3 months.
- interventionNames
- Drug: Oral Immunomodulator
- Drug: Vaginal Ovule
- type
- ACTIVE_COMPARATOR
- label
- Standard Supportive Care
- description
- Participants receive standard supportive care for 3 months according to routine clinical practice.
- interventionNames
- Other: Standard Supportive Care
Primary outcomes (1)
- measure
- HPV clearance rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18-65 years. * Confirmed persistent high-risk human papillomavirus (HR-HPV) infection. * Histologically confirmed CIN 1 or cytological diagnosis of ASC-US or LSIL. * Eligible for conservative follow-up without immediate excisional treatment. * Ability to provide written informed consent and comply with study procedures. Exclusion Criteria: * HSIL, CIN2, CIN3, adenocarcinoma in situ, or invasive cervical cancer. * Pregnancy or breastfeeding. * Immunodeficiency or current immunosuppressive therapy. * Previous treatment for cervical dysplasia within the last 6 months. * Planned colposcopy, cervical biopsy, or LEEP during the 3-month study period. * Known hypersensitivity to any study intervention. * Participation in another interventional clinical trial.
References
Publications (0)
Data not yet available