Clinical trial NCT04002154: Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV
Official title: Ensayo clínico, Aleatorizado, Abierto, de Grupos Paralelos y Con Grupo Control, Para Explorar la Eficacia Del Gel PAPILOCARE en la reparación de la Mucosa cérvico-vaginal Con Lesiones Causadas Por VPH (Ensayo Clínico PALOMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus Infection
Human Papilloma Virus
Cervix Lesion
Keywords: HPV
Lead sponsor: Procare Health Iberia S.L.
Sponsor class: INDUSTRY
Collaborators: name: Adknoma Health Research
First posted: 2019-06-28
Enrollment: 134
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1).

Detailed description: Phase II, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel Papilocare in the repair of the cervico-vaginal mucosa with lesions caused by HPV. All the patients included in the study will be Randomized (1:1:1) to Arm A (Papilocare schedule A), Arm B (Papilocare schedule B) and Arm C (usual clinical practice -without treatment-). Selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. Patients will visit the site into a total of 5 visits throughout the study.

Eligibility criteria: Inclusion Criteria:

1. Woman between the ages of 30 and 65 (both included).
2. Able to read and understand the Patient Information Sheet and the Informed Consent form.
3. Accept participation in the study and sign the Informed Consent form.
4. Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
5. Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
6. Is capable, at the discretion of the investigator, of complying with the requirements of the study protocol and without impediments to follow the instructions and evaluations throughout it.

Exclusion Criteria:

1. Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
2. Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
3. To had been vaccinated against HPV.
4. Other symptomatic vulvovaginal infections.
5. Surgical cervical excision in the last year or total hysterectomy.
6. Previous history of gynecological cancer.
7. Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the study.
8. Any planned surgery that prevents the correct compliance with the protocol.
9. Use of vaginal contraceptives or other vaginal hormonal treatments.
10. Contraindications for Papilocare gel use or known allergies to any of its components.
11. Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

Primary outcomes:
measure: Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
timeFrame: 6 months
Secondary outcomes:
measure: Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image
timeFrame: 3 and 12 months
measure: Reeptielization of the cervico-vaginal mucosa measured by a likert scale.
timeFrame: 3,6 and 12 months
measure: Vaginal health status measured by Bachmann Index.
timeFrame: 3,6 and 12 months
measure: Satisfaction of papilocare gel use measured by likert scale.
timeFrame: 3 and 6 months
measure: Therapeutic compliance
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Clínica Diatros - TEKNON
city: Barcelona
country: Spain
facility: Women´s Health Institute
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Madrid
country: Spain
facility: Gabinete Médico Velázquez
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Instituto Palacios de Salud y Medicina de la Mujer
city: Málaga
country: Spain
facility: Hospital Quirón Málaga
Study officials:
affiliation: Hospital os Palma de Mallorca
name: Javier Cortés Bordoy, MD
role: STUDY_CHAIR
References:
citation: 2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.