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

i+Med S.Coop.

Status: Completed

Conditions: Vulvar Atrophy

Treatments: Device: BtHIntimate® Injectable Hyaluronic Acid Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07402395

BtHCi-PIC01-2024

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women (≥18 years).
• Women with mild or moderate vulvar atrophy, including deflation or vulvar ptosis, or with visible signs of genital aging, or women seeking aesthetic improvement of the vulvovaginal area, including peri-menopausal or women with genitourinary syndrome of menopause (GSM).
• Ability and willingness to comply with all study visits and procedures.
• Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.
• For women of childbearing potential: negative pregnancy test and agreement to use reliable contraception during the study (hormonal contraception, IUD/IUS, condoms, diaphragm with spermicide, vasectomized partner, or true abstinence).

Exclusion criteria

• Allergy or hypersensitivity to any component of BtH Intimate 2.0%.
• Pregnancy or planned pregnancy, or breastfeeding.
• Active infection or pathology in the area to be treated.
• Presence of bacterial, fungal, or viral infection in or near the vulvovaginal region, or current treatment for such conditions.
• Known tendency to develop hypertrophic scars or keloids.
• Signs of inflammation in or near the treatment area, or receiving treatment for inflammation.
• History of any vulvovaginal rejuvenation procedure within the last 6 months or during the study (e.g., laser, radiofrequency, electrotherapy, dermal fillers, PRP, etc.).
• Unrealistic or disproportionate expectations regarding treatment outcomes.
• Incorrectly selected participants (those found retrospectively to fail inclusion or meet exclusion criteria) will be replaced.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

BtHIntimate® Injectable Hyaluronic Acid Treatment

Experimental group

Description:

Participants in this single-arm study will receive a single intradermal infiltration of BtH Intimate 2.0% intended to restore volume and improve the aesthetic appearance, hydration, and firmness of the vulvovaginal area.

Treatment:

Device: BtHIntimate® Injectable Hyaluronic Acid Treatment