We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002154
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
Adknoma Health Research
Information provided by (Responsible Party):
Procare Health Iberia S.L.

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

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.

Layout table for study information
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
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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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).

  3. 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.

  4. 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).

  5. Therapeutic compliance [ Time Frame: 3 and 6 months ]
    Evaluate the therapeutic compliance from the start of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
Layout table for location information
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
Layout table for investigator information
Study Chair: Javier Cortés Bordoy, MD Hospital os Palma de Mallorca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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)

Layout table for additional information
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.:
HPV
Additional relevant MeSH terms:
Layout table for MeSH terms
Papillomavirus Infections
Papilloma
Virus Diseases
Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Tumor Virus Infections