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

Human Papilloma Virus Clinical Trial

— PALOMA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04002154
• Other study ID #: PHPC-201501
• Status: Completed
• Phase: N/A
• Start date: October 19, 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2021
• Source: Procare Health Iberia S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 28, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Lesion
• Human Papilloma Virus
• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Clínica Diatros - TEKNON	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Women´s Health Institute	Barcelona
Spain	Gabinete Médico Velázquez	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Instituto Palacios de Salud y Medicina de la Mujer	Madrid
Spain	Hospital Quirón Málaga	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
Procare Health Iberia S.L.	Adknoma Health Research

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Therapeutic compliance	Evaluate the therapeutic compliance from the start of treatment	3 and 6 months