Trials Sponsors Conditions Drugs Pricing

Conditions

Aesthetics Procedure

Keywords

hyaluronic acidcrosslinkingskin rejuvenationfacial volume restorationfacial wrinkle and foldssoft tissue augmentation

Outcome Measures

Primary Outcomes (4)

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.

Secondary Outcomes (2)

Exploratory objective - Global Aesthetic Improvement Scale (GAIS) by investigator
6-9 months
Exploratory objective - Subjective self assessment of the treatment by the patient
6-9 months

Study Arms (1)

BtHCROSS®

EXPERIMENTAL

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Device: BtHCROSS®

Interventions

BtHCROSS®Device

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

BtHCROSS®

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age30 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

Sponsors & Collaborators

Dr. Goya Análisis, SL.
Industrycollaborator
i+Med S.Coop.
Industrylead

Study Sites (1)

Complutense Medical Center (Virtus Group)

Madrid, Madrid, 28805, Spain

Enrollment

203 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 24, 2025

Study Start

April 26, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (1)

BtHCROSS®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (1)

BtHCROSS®

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations