Clinical trial · Interventional
Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance
Papilocare®: Effects on Regression of Histologically Confirmed Cervical Intraepithelial Lesions 1 and Tolerance.
NCT04624568CI-TRIAL-00067153PAPILOCAREcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
clinical trial comparing the regression rate after 12 months of histologically confirmed cervical intraepithelial lesions 1 in 2 parallel groups. One group using the vaginal gel Papilocare® for 6 months and one group without any treatment.
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 |
|---|---|---|---|
| Cervix Lesion | — | UNRESOLVED | — |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
| Squamous Intraepithelial Lesions of the Cervix | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PAPILOCARE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Papilocare group
- description
- Papilocare® for 6 months according to the following schedule: 1 self-applying single dose per day for 21 days over 28 during the first month, then 1 day over 2 during the following 5 months, with a 7-day break during the menstrual period. (This break must be respected even in menopausal women or women undergoing artificial amenorrhea (amenorrhea induced by certain contraceptives: implant, hormonal IUD, micro-progestogen).
- interventionNames
- Device: PAPILOCARE
- type
- NO_INTERVENTION
- label
- Control group
- description
- No treatment for 12 months. Smear and HPV test will be perform by all patients at 6 and 12 months
Primary outcomes (1)
- measure
- Cervical cytology normalization after 12 months.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 25 years old or older. * With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area. * With complete colposcopy, performed less than 3 months prior the inclusion * With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy. Exclusion Criteria: * Women under guardianship or curatorship * Women under the protection of justice * Women not affiliated with a social security system * Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of inclusion for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women. * Immunodepressed women (HIV, immunosuppressive treatments ...) * Woman using vaginal contraceptives (ring, spermicides, cervical cap; because of risk of interaction) NB: Papilocare is compatible with the use of condoms and intrauterine devices. * Known allergy to one of the components * Patients with low-grade histology with HSIL - ASC-H - AGC smear will not be included. The cyto-colposcopic discordance suggests a high-grade lesion that would not have been biopsied at colposcopy. * Patients undergoing laser or conization treatment according to the recommendations of INCa 2016 will not be included; namely: persistence of CIN 1 for more than 24 months on at least 2 different colposcopies; high-grade squamous intraepithelial histological lesions; adenocarcinoma in situ. * Participation in another interventional study
References
Publications (4)
- BACKGROUNDBosch FX, Lorincz A, Munoz N, Meijer CJ, Shah KV. The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002 Apr;55(4):244-65. doi: 10.1136/jcp.55.4.244. PMID 11919208
- BACKGROUNDOstor AG. Natural history of cervical intraepithelial neoplasia: a critical review. Int J Gynecol Pathol. 1993 Apr;12(2):186-92. PMID 8463044
- BACKGROUNDLousuebsakul V, Knutsen SM, Gram IT, Akin MR. Clinical impact of atypical squamous cells of undetermined significance. A cytohistologic comparison. Acta Cytol. 2000 Jan-Feb;44(1):23-30. doi: 10.1159/000326220. PMID 10667155
- RESULTBansal N, Wright JD, Cohen CJ, Herzog TJ. Natural history of established low grade cervical intraepithelial (CIN 1) lesions. Anticancer Res. 2008 May-Jun;28(3B):1763-6. PMID 18630456