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

i+Med S.Coop.203 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

203

Conditions

Aesthetics Procedure

Interventions

BtHCROSS®DEVICE

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Complutense Medical Center (Virtus Group)

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Determine the BtHCROSS' efficacy in improving the facial volume loss

To determine how effective BtHCROSS is in improving volume loss in the mid-face region comparing the skin's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the MFVLS (Mid-Face Volume Loss Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.

Time frame: 6 months

Determine the BtHCROSS' efficacy in improving facial wrinkle severity

To determine how effective BtHCROSS is in improving wrinkle severity comparing the skin's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the WSRS(Wrinkle Severity Rating Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.

Time frame: 6 months

Determine the BtHCROSS' efficacy in improving lip fullness

To determine how effective BtHCROSS is in improving vlip fullness comparing the lips's condition before and after treatment. This evaluation is carried out by medical professionals using validated aesthetic scales, depending on the specific product model. The measurements were done using the LFGS (Lip Fullness Grading Scale) a 0-5 scale, 0 being good outcome and 5 being the worst outcome.

Time frame: 6 months

Safety Outcome

The study evaluates the safety of BtHCROSS by systematically recording and analyzing any serious adverse events that occur during the treatment period.

Time frame: 9 months

Secondary Outcomes

Exploratory objective - Global Aesthetic Improvement Scale (GAIS) by investigator

To assess overall aesthetic improvement using the Global Aesthetic Improvement Scale (GAIS), a widely used 5-point Likert scale ranging from "Exceptional Improvement" (5) to "Worsening" (1). This measurements were done by the investigator.

Data from ClinicalTrials.gov

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