Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV (PALOMA)

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)

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).

Study Overview

• Status: Completed
• Conditions: Human Papilloma Virus Infection; Human Papilloma Virus; Cervix Lesion
• Intervention / Treatment: Device: Papilocare vaginal gel

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08017
    • Women´s Health Institute
  • Barcelona, Spain, 08017
    • Clínica Diatros - TEKNON
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28031
    • Hospital Infanta Leonor
  • Madrid, Spain, 28001
    • Gabinete Médico Velázquez
  • Madrid, Spain, 41720
    • Instituto Palacios de Salud y Medicina de la Mujer
  • Málaga, Spain, 29004
    • Hospital Quirón Málaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - papilocare alternative days; Arm A: scheme A (21 days / 1 cannula per day + 7 days rest) x 1 month + alternate days up to 6 months (except for menstruation days)	Device: Papilocare vaginal gel; Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
Experimental: B - papilocare semiintensive; Arm B: scheme B (21 days / 1 cannula per day + 7 days rest) x 3 months + alternate days up to 6 months (except menstruation days)	Device: Papilocare vaginal gel; Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
No Intervention: C - standard of care; Arm C: usual clinical practice: no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image	Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image, 6 months after the start of treatment.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image	Evaluate the repairment of the cervico-vaginal mucosa in positive HPV women with a cytological result of squamous atypia of undetermined significance (ASC-US) or low-grade squamous lesion (LSIL) or glandular atypia of undetermined significance (AG-US), with concordant colposcopic image at 3 and 12 months after the start of treatment.	3 and 12 months
Reeptielization of the cervico-vaginal mucosa measured by a likert scale.	Evaluate the reeptielization of the cervico-vaginal mucosa months after the start of treatment measured by likert scale, using a total of 5 points (1 is severe ectopy + external bleeding, 2 is severe or extensive ectopy:> 50%, 3 is moderate ectopy: 25-50%, 4 is mild ectopy: <25% and 5 is no ectopy).	3,6 and 12 months
Vaginal health status measured by Bachmann Index.	Evaluate vaginal health status from the start of treatment measured by Bachmann Index, it contains 5 domains that evaluate elasticity, type of secretion, pH, epithelial integrity and moisture, scoring each of them from 1 to 5, considering the maximum score as the best vaginal health status.	3,6 and 12 months
Satisfaction of papilocare gel use measured by likert scale.	Evaluate the satisfaction of papilocare gel use by the patients after the start of treatment measured by likert scale, it is a single-item instrument that assesses the degree of satisfaction experienced by the patient with a graded response of 7 values ranging from 1 (satisfied) to 7 (not satisfied at all).	3 and 6 months
Therapeutic compliance	Evaluate the therapeutic compliance from the start of treatment	3 and 6 months

Collaborators and Investigators

• Sponsor: Procare Health Iberia S.L.
• Collaborators: Adknoma Health Research
• Investigators: Study Chair: Javier Cortés Bordoy, MD, Hospital os Palma de Mallorca

Publications and helpful links

General Publications

• 2021 ASCCP Poster Presentations. J Low Genit Tract Dis. 2021 Apr 1;25(2S):9-11. doi: 10.1097/LGT.0000000000000602. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2015
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: HPV
• Additional Relevant MeSH Terms: Virus Diseases; Infections; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; DNA Virus Infections; Tumor Virus Infections; Neoplasms, Squamous Cell; Papillomavirus Infections; Papilloma
• Other Study ID Numbers: PHPC-201501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It must be discussed with investigators team
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No