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| Name | Class |
|---|---|
| Dr. Goya Análisis, SL. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BtHCROSS® | Experimental | Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BtHCROSS® | Device | Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complutense Medical Center (Virtus Group) | Madrid | Madrid | 28805 | Spain |
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| Exploratory objective - Subjective self assessment of the treatment by the patient |
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) |
| 6-9 months |