NCT07402395

Clinical Study on the Safety and Efficacy of an Injectable Hyaluronic Acid for Improving the Aesthetic Rejuvenation of the Vulvovaginal Area

Efficacy and Safety of BtH Intimate 2.0% (Injectable Cross-Linked Hyaluronic Acid) in the Volumization and Aesthetic Rejuvenation of the Female Vulvovaginal Area: A Prospective Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: i+Med S.Coop. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-center, before-after study evalutated BtH Intimate 2.0%, a cross-linked hyaluronic acid injectable used to restore volume and improve the aesthetic appearance and hydration of the vulvovaginal area in adult women. Forty participants with mild to moderate vulvar atrophy or genital aging signs received a single treatment, with an optional touch-up at 4 weeks, and were followed for six months. The primary objectives were to measure global aesthetic improvement using the GAIS scale and to assess safety through the recording of serious adverse events. Secondary measures included patient satisfaction, sexual function (FSFI), symptom improvement (VAS), tissue hydration, and overall patient-reported benefit. Expected risks were mild and transient, consistent with HA fillers, while the intervention aimed to enhance comfort, appearance, and quality of life.

Conditions

• Vulvar Atrophy

Interventions

Type	Name	Description
DEVICE	BtHIntimate® Injectable Hyaluronic Acid Treatment	BtHIntimate 2.0% is administered to the labia majora and/or mons pubis according to individual clinical needs. An optional touch-up may be performed at the 4-week follow-up visit if deemed necessary by the investigator. All participants are followed for 6 months, during which aesthetic outcomes, tissue hydration, patient-reported symptoms, sexual function, satisfaction, and safety events are evaluated.

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-09-02
• Completion: 2025-11-26
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Spain