Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by… (NCT04210336) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Evaluate Papilocare® Gel Efficacy Into Repairment of Cervical Lesions Caused by HPV
Spain200 participantsStarted 2018-08-07
Plain-language summary
Clinical Trial phase III, randomized, double-blind, parallel-group, controlled using lactic acid gel to evaluate the efficacy of Papilocare gel in the repair of cervical lesions caused by HPV.
The study is divided into two parts. All patients included in the study will be randomized (1: 1) to one of the 2 study groups, Papilocare or lactic acid gel, using a randomization list and in double-blind conditions.
Who can participate
Age range30 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. Woman between the ages of 30 and 65 (both included).
✓. Able to read and understand the Patient Information Sheet and informed consent
✓. Accept participation in the study and sign the Informed Consent.
✓. Cytological result of ASC-US or LSIL, with concordant colposcopic image, at most 3 months before the selection visit. It is considered concordant with ASCUS and LSIL, a colposcopic result of normality, of non-specific findings or of type 1 changes.
✓. Positive HPV according to cobas 4800 technique (high-risk HPV) carried out in a selection visit (or positive available at most 3 months prior to the baseline visit).
✓. Women vaccinated and not vaccinated against HPV.
✓. Is able, at the discretion of the researcher, to comply with the requirements of the study and without impediments to follow the instructions and assessments throughout it.
Exclusion criteria
✕. Clinically relevant alterations of the immune system or any other autoimmune disease or in treatment with immunosuppressants.
✕. Other cytological results other than those provided for in the inclusion criteria.
✕. Baseline LSIL biopsies with CIN-3.
✕. Abnormal undiagnosed genital bleeding (during the 6 months prior to the selection visit)