Clinical Trial to Explore the Papilocare Gel Efficacy to Repair the Cervico-vaginal Mucosa With Lesions Caused by HPV (PALOMA)
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| ClinicalTrials.gov Identifier: NCT04002154 |
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Recruitment Status :
Completed
First Posted : June 28, 2019
Last Update Posted : February 16, 2021
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Sponsor:
Procare Health Iberia S.L.
Collaborator:
Adknoma Health Research
Information provided by (Responsible Party):
Procare Health Iberia S.L.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Human Papilloma Virus Infection Human Papilloma Virus Cervix Lesion | Device: Papilocare vaginal gel | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 134 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | October 19, 2015 |
| Actual Primary Completion Date : | July 31, 2018 |
| Actual Study Completion Date : | February 28, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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)
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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 |
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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)
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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 |
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No Intervention: C - standard of care
Arm C: usual clinical practice: no treatment
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Primary Outcome Measures :
- Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image [ Time Frame: 6 months ]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.
Secondary Outcome Measures :
- Repairment of the cervico-vaginal mucosa in positive HPV women measured by normal cytology with concordant colposcopy image [ Time Frame: 3 and 12 months ]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.
- Reeptielization of the cervico-vaginal mucosa measured by a likert scale. [ Time Frame: 3,6 and 12 months ]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).
- Vaginal health status measured by Bachmann Index. [ Time Frame: 3,6 and 12 months ]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.
- Satisfaction of papilocare gel use measured by likert scale. [ Time Frame: 3 and 6 months ]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).
- Therapeutic compliance [ Time Frame: 3 and 6 months ]Evaluate the therapeutic compliance from the start of treatment
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| Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Woman between the ages of 30 and 65 (both included).
- Able to read and understand the Patient Information Sheet and the Informed Consent form.
- Accept participation in the study and sign the Informed Consent form.
- Cytological result of ASC-US or LSIL or AG-US, with matching colposcopic image, maximum 3 months before the screening visit.
- Positive HPV by PCR performed at the screening visit (or positive available at most 3 months prior to the baseline visit).
- 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:
- Clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants.
- Non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit).
- To had been vaccinated against HPV.
- Other symptomatic vulvovaginal infections.
- Surgical cervical excision in the last year or total hysterectomy.
- Previous history of gynecological cancer.
- Participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the study.
- Any planned surgery that prevents the correct compliance with the protocol.
- Use of vaginal contraceptives or other vaginal hormonal treatments.
- Contraindications for Papilocare gel use or known allergies to any of its components.
- Women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002154
Locations
| Spain | |
| Hospital General Universitario de Alicante | |
| Alicante, Spain, 03010 | |
| Clínica Diatros - TEKNON | |
| Barcelona, Spain, 08017 | |
| Women´s Health Institute | |
| Barcelona, Spain, 08017 | |
| Hospital de la Santa Creu i Sant Pau | |
| Barcelona, Spain, 08041 | |
| Gabinete Médico Velázquez | |
| Madrid, Spain, 28001 | |
| Hospital Infanta Leonor | |
| Madrid, Spain, 28031 | |
| Hospital Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Instituto Palacios de Salud y Medicina de la Mujer | |
| Madrid, Spain, 41720 | |
| Hospital Quirón Málaga | |
| Málaga, Spain, 29004 | |
Sponsors and Collaborators
Procare Health Iberia S.L.
Adknoma Health Research
Investigators
| Study Chair: | Javier Cortés Bordoy, MD | Hospital os Palma de Mallorca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Procare Health Iberia S.L. |
| ClinicalTrials.gov Identifier: | NCT04002154 |
| Other Study ID Numbers: |
PHPC-201501 |
| First Posted: | June 28, 2019 Key Record Dates |
| Last Update Posted: | February 16, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | It must be discussed with investigators team |
| Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Procare Health Iberia S.L.:
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HPV |
Additional relevant MeSH terms:
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Papillomavirus Infections Papilloma Virus Diseases Infections Neoplasms, Squamous Cell |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms DNA Virus Infections Tumor Virus Infections |