Aesthetics ProcedureNCT07301619
Post-market Study on BtHCROSS® for Restoring Facial Volume After a Single Injection
A study testing BtHCROSS® in people with Aesthetics Procedure, run by i+Med S.Coop. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Aesthetics Procedure
- What is being tested?
- BtHCROSS®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteSpain
- Study dates
- 26 Apr 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aesthetics Procedure
- Being tested
- BtHCROSS®
- Keywords
- hyaluronic acid, crosslinking, skin rejuvenation, facial volume restoration, facial wrinkle and folds, soft tissue augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BtHCROSS®Device
Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked
| Study group | Role | What they receive |
|---|---|---|
| BtHCROSS® | Experimental | Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked Receives: Device: BtHCROSS® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9 months
Secondary outcomes (2)
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.
Measured: 6-9 months
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)
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start26 Apr 2022
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aesthetics ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- i+Med S.Coop.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301619
- Sponsor's protocol ID
- BtHCROSS-PIC01-2021
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Clinical Investigation to Evaluate the Efficacy and Safety of BtHCROSS for Restoring Facial Volume and Filling Facial Folds and Wrinkles
- ClinicalTrials.gov ID
- NCT07301619
- Acronym / sponsor ID
- BtHCROSS-PIC01-2021
- Conditions
- Aesthetics Procedure
- Keywords
- hyaluronic acid, crosslinking, skin rejuvenation, facial volume restoration, facial wrinkle and folds, soft tissue augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- i+Med S.Coop.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Goya Análisis, SL.
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BtHCROSS® | Experimental | Device: BtHCROSS®Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BtHCROSS®Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked | Device | BtHCROSS® |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Exploratory objective - Global Aesthetic Improvement Scale (GAIS) by investigator
Time frame: 6-9 months
Exploratory objective - Subjective self assessment of the treatment by the patient
Time frame: 6-9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BtHCROSS® in people with Aesthetics Procedure, run by i+Med S.Coop. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the BtHCROSS' efficacy in improving the facial volume loss (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.