Post-market Study on BtHCROSS® for Restoring Facial Volume After a Single Injection

i+Med S.Coop.

Status

Completed

Conditions

Aesthetics Procedure

Treatments

Device: BtHCROSS®

Study type

Interventional

Funder types

Industry

Identifiers

NCT07301619

BtHCROSS-PIC01-2021

Details and patient eligibility

About

This clinical study investigated the safety and effectiveness of BtHCROSS, a hyaluronic acid-based injectable used to restore facial volume and reduce wrinkles. Adults aged 30 to 70 received a single treatment and were monitored over 9 months. Researchers assessed improvements in facial appearance and recorded any side effects. The results aimed to support the product's continued safe use in aesthetic treatments.

Enrollment

203 patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, aged between 30 and 70 years.
Individuals showing mild to moderate signs of facial skin aging (such as loss of brightness, hydration, and/or firmness).
Sufficient willingness and ability, as judged by the investigator, to complete the study questionnaires.

Exclusion criteria

Pregnant or breastfeeding women.
Known allergy or sensitivity to hyaluronic acid or any other ingredient in the product.
Individuals who have undergone any wrinkle correction or rejuvenation procedures in the past 6 months or during the study (e.g., radiofrequency, electrotherapy, botulinum toxin, thread lifts, or laser techniques).
Autoimmune or inflammatory diseases, or any condition affecting skin health that could interfere with the treatment.
History of any illness or infection in the injection area during the study.
Lymphatic and/or vascular disorders.
Individuals with unrealistic expectations about the treatment outcomes.
Previous facial surgery.
Active infection in the treatment area.
Blood coagulation disorders. Subjects on anticoagulant therapy are excluded, even without a diagnosed coagulation issue, unless cleared by their prescribing specialist.
Subjects with unrealistic expectations regarding the likely outcomes of the treatment.