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Completed

NCT Number: NCT07301619

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

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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Key information

Conditions

Aesthetics Procedure

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complutense Medical Center (Virtus Group)

Madrid, 28805, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BtHCROSS®

Device

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Primary outcomes

  1. Determine the BtHCROSS' efficacy in improving the facial volume loss

    Time frame: 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.

  2. Determine the BtHCROSS' efficacy in improving facial wrinkle severity

    Time frame: 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.

  3. Determine the BtHCROSS' efficacy in improving lip fullness

    Time frame: 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.

  4. Safety Outcome

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Exploratory objective - Subjective self assessment of the treatment by the patient

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

i+Med S.Coop.

Industry

Collaborators

  • Dr. Goya Análisis, SL.

Registry information

Official study title

Post-marketing Clinical Investigation to Evaluate the Efficacy and Safety of BtHCROSS for Restoring Facial Volume and Filling Facial Folds and Wrinkles

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.