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

NCT ID: NCT07301619

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2023-02-17

Brief Summary

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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.

Detailed Description

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Conditions

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Aesthetics Procedure

Keywords

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hyaluronic acid crosslinking skin rejuvenation facial volume restoration facial wrinkle and folds soft tissue augmentation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BtHCROSS®

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Group Type EXPERIMENTAL

BtHCROSS®

Intervention Type DEVICE

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Interventions

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BtHCROSS®

Single injection of 1 ml of viscoelastic sodium hyaluronate solution crosslinked

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Goya Análisis, SL.

INDUSTRY

Sponsor Role collaborator

i+Med S.Coop.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Complutense Medical Center (Virtus Group)

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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BtHCROSS-PIC01-2021

Identifier Type: -

Identifier Source: org_study_id