Clinical Investigation to Assess Safety and Efficacy of INNEA AQUA in Adult Women With Vulvo-Vaginal Atrophy (VVA)

Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).

To assess the Safety and efficacy of INNEA AQUA

Study Overview

• Status: Active, not recruiting
• Conditions: Vulvo Vaginal Atrophy
• Intervention / Treatment: Device: product: Innea Aqua vaginal use; Device: arm 2: standard of care

Detailed Description

Clinical investigation to assess safety and efficacy of INNEA AQUA in adult women with Vulvo-Vaginal Atrophy (VVA).

To assess the Safety and efficacy of INNEA AQUA

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Romania
    • Bucharest, Romania, Romania, 011132
      • Obstretics and Gynaecology Filantropia Clinical Hospital
    • Bucharest, Romania, Romania, 022441
      • Nicolae Malaxa Clinical Hospital
    • Bucharest, Romania, Romania, 030863
      • AMCA Medical Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult women aged 18-75 (both fertile and post-menopausal)
• Vulvovaginal atrophy diagnostic
• Signed written informed consent.
• Vaginal Ph more than 4.5
• Willing to sign the informed consent form
• Willing to comply with the clinical investigation visits.

Exclusion Criteria:

• patients who tend to develop hypertrophic scarring,
• patients with a history of autoimmune disease or who are receiving immune therapy,
• patients who are known to be hypersensitive or allergic to hyaluronic acid and other INNEA AQUA components,
• pregnant or breastfeeding women,
• patients under 18 years of age,
• vagina with hypertrophic scars from different etiology,
• patients with presence of ≥ stage 2 apical pelvic organ prolapse,
• patients with stress urinary incontinence,
• patients with vaginismus, vulvovaginal or urinary tract infection,
• patients with Hemorrhagic or neoplastic genital pathologies or hormone-dependent tumor
• patients with genital bleeding of unknown etiology, recurrent porphyria, uncontrolled epilepsy, heart conduction disorders, recurrent angina, rheumatic fever, previous vulvovaginal or uro-gynecological surgery, and hemostatic disorders,
• Anticoagulated patients or patients receiving platelet aggregation inhibitors should not be treated with INNEA AQUA,
• INNEA AQUA must not be used in areas presenting inflammatory and/or infectious processes (e.g., papilloma, herpes). INNEA AQUA must not be used in association with other invasive treatments,
• Avoid using in combination with any other concomitant therapies for same indication;
• Patients who are using substances that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may, as with any injection, experience increased bruising or bleeding at treatment sites.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: randomized to the treatment Innea Aqua; 31 women (18-75) treated with product Innea Aqua. 1 injection of the product and after 30 days another injection	Device: product: Innea Aqua vaginal use; product object of the investigation: Innea Aqua for vaginal use, 2 mL product. Labelled as Innea Aqua.
Active Comparator: Arm 2: randomized to the treatment to the standard of care; standard of care tratment	Device: arm 2: standard of care; the comparator is the standard of care selected by the centre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety: Incidence of AE and SAE	To evaluate the safety of INNEA AQUA in adult participants. Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: change in pruritus	Change in Pruritus (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: Change in soreness	Change in Soreness (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
Efficacy: change in dyspareunia	Change in Dyspareunia (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in irritation	Change in Irritation (0-10 visual analogue scales (VAS)) on Day 0, Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of pH	Vaginal Ph Normalization	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in vaginal moisture	Change in Vaginal moisture - Modified Schirmer test (mm) change on Day 30, Day 51, and Day 120 compared with baseline	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: change in VHX	Change in Vaginal Health Index (VHI) score on Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of vaginal aging	Change in Day-to-Day Impact of Vaginal Aging Questionnaire on Day 30, Day 51, and Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
safety (AE/SAE)	Incidence of adverse events, early withdrawal rate due to AEs, and device deficiencies, whether serious or not	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the patient	Participant satisfaction in using the Device (PGI-I) Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: satisfaction of the investigator	Investigator satisfaction in using the Device (VAS) Day 120	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection
efficacy: evaluation of quality of life	Change in baseline score in QoL score when compared to Day 30, 51 and 120.	From enrollment to the end of treatment and second follow up visit at 120 days from the first injection

Collaborators and Investigators

• Sponsor: Innate srl
• Collaborators: CEBIS International

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: vaginal atrophy; hyaluronic acid; VVA; vulvo vaginal atrophy
• Other Study ID Numbers: INN-AQA-10/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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