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

December 10, 2025 updated by: i+Med S.Coop.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28805
        • Complutense Medical Center (Virtus Group)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BtHCROSS®
Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked
Device: BtHCROSS®
Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-9 months
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)
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i+Med S.Coop.

Collaborators

Dr. Goya Análisis, SL.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Actual)

February 17, 2023

Study Completion (Actual)

February 17, 2023

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BtHCROSS-PIC01-2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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