Aesthetics Procedure
Conditions
Keywords
hyaluronic acid, crosslinking, skin rejuvenation, facial volume restoration, facial wrinkle and folds, soft tissue augmentation
Brief summary
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.
Interventions
DEVICEBtHCROSS®
Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked
Sponsors
Dr. Goya Análisis, SL.
i+Med S.Coop.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the BtHCROSS' efficacy in improving the facial volume loss | 6 months | 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. |
| Determine the BtHCROSS' efficacy in improving facial wrinkle severity | 6 months | 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. |
| Determine the BtHCROSS' efficacy in improving lip fullness | 6 months | 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. |
| Safety Outcome | 9 months | The study evaluates the safety of BtHCROSS by systematically recording and analyzing any serious adverse events that occur during the treatment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory objective - Global Aesthetic Improvement Scale (GAIS) by investigator | 6-9 months | 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. |
| Exploratory objective - Subjective self assessment of the treatment by the patient | 6-9 months | After the final treatment session, each participant self-assessed their perceived improvement through a likert-type 5 point brief questionnaire, which answers were (worsening, no changes, improvement, important improvement and exceptional improvement) |
Countries
Spain
Outcome results
None listed