Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:38 PM
Study NCT ID:
NCT07441135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Aesthetic Improvement Scale (GAIS)', 'timeFrame': 'From enrollment until study completion (9 months)', 'description': 'Investigator-rated overall aesthetic improvement of the treated area (5-point Likert scale). Improvement (scores from 3 to 5) in ≥60% of participants at V5 or V6 is considered clinically relevant.'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'From enrollment until study completion (9 months)', 'description': 'Frequency of serious adverse events occurring at any point during the study.'}], 'secondaryOutcomes': [{'measure': 'Subject Satisfaction (Likert Scale)', 'timeFrame': 'Follow up visits: 4, 12, 24 and 36 weeks.', 'description': 'Participant-reported satisfaction (5-point scale): very satisfied, satisfied, slightly satisfied, indifferent and dissatisfied, this scale will be recorded at follow-up visits.'}, {'measure': 'Aesthetic Parameter Scores (VAS)', 'timeFrame': 'From enrollment until study completion (9 months)', 'description': 'Investigator-rated evaluation (VAS from 0 to 10) of volume, symmetry, shape, firmness, uniformity, hydration, elasticity, tonicity, and general appearance. Improvement from baseline is calculated.'}, {'measure': 'Quality of Life - Body Self-Esteem Scale (SEC)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Change from baseline in the Body Self-Esteem Scale (1-10 points), 1 being no satisfaction and 10 being very satisfied.'}, {'measure': 'Quality of Life - Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Participant-reported impression of improvement (1-7 scale). Responders are considered those reporting "a little better"(3), "much better"(2), or "very much better"(1).'}, {'measure': 'Biometric Measurements (Moisturemap)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with MoistureMap which measures hydration by assessing water content in the stratum corneum and will quantify improvements in skin moisture levels.'}, {'measure': 'Biometric Measurements (Corneometer)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with Corneometer which measures hydration by assessing water content in the stratum corneum and will quantify improvements in skin hydration levels.'}, {'measure': 'Biometric Measurements (Cutometer)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with Cutometer, a suction-based device that evaluates biomechanical properties, will measure firmness and elasticity of the treated area.'}, {'measure': 'Skin contour measurements (AEVA 3D-HE2)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin contour by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.'}, {'measure': 'Skin volume measurements (AEVA 3D-HE2)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin volume by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.'}, {'measure': 'Skin roughness measurements (AEVA 3D-HE2)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin roughness by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.'}, {'measure': 'Skin surface smoothness measurements (AEVA 3D-HE2)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Objective skin and tissue changes will be evaluated with AEVA 3D-HE2, a high-resolution 3D imaging system, will assess skin surface smoothness by capturing precise topographic data, which will be compared with baseline values to determine treatment-related changes over time.'}, {'measure': 'Volume of Product Injected', 'timeFrame': 'From baseline to last treatment session (up to 12 weeks)', 'description': 'Total amount of BtH Body 2.2% administered per participant, including touch-up session if performed.'}, {'measure': 'Future-Use Questionnaire (Participant)', 'timeFrame': 'Week 36 (end of study)', 'description': 'Participant expectations and willingness to repeat or recommend the treatment. Assessed at V5.'}, {'measure': 'Usability Questionnaire (Investigator)', 'timeFrame': 'Week 36 (end of study)', 'description': 'Investigator-reported usability of the product (at V5).'}, {'measure': 'Incidence of Non-Serious Adverse Events (AEs)', 'timeFrame': 'From enrollment to study completion (9 months)', 'description': 'Frequency, severity, and characteristics of non-serious events throughout the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyaluronic Acid', 'Body Contouring', 'Soft-Tissue Augmentation', 'Aesthetic Enhancement'], 'conditions': ['Aesthetic Body Volume Loss']}, 'descriptionModule': {'briefSummary': 'This clinical investigation is a prospective, interventional, single-center study designed to assess the safety and effectiveness of BtH Body 2.2%, a cross-linked hyaluronic acid injectable intended for aesthetic volumization and contouring of large body areas. The study enrolls 80 adult participants who seek aesthetic improvement in the gluteal region, thighs, or abdomen. Each participant will receive a single session of subcutaneous injections, with the option for a touch-up treatment at four weeks if clinically justified, and will be followed for a total of nine months.\n\nThe primary aim of the study is to determine whether BtH Body 2.2% produces a clinically relevant improvement in the treated area, assessed by the Global Aesthetic Improvement Scale (GAIS), and to evaluate the safety profile of the product by monitoring the incidence of serious adverse events throughout the study period. Secondary assessments will examine patient satisfaction, investigator-rated changes in aesthetic parameters such as volume, firmness, uniformity, elasticity, and overall appearance, as well as improvements in quality of life using validated questionnaires, including the Body Self-Esteem Scale and the Patient Global Impression of Improvement (PGI-I). Objective measurements of skin hydration, elasticity, firmness, and topography will also be obtained using specialized biometric devices.\n\nThe overall goal is to generate robust clinical evidence supporting the use of BtH Body 2.2% for safe and effective body contouring and volumization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Presence of extensive body areas (gluteal region, thighs, or abdomen) showing aesthetic concerns such as:\n* loss of volume\n* flaccidity\n* contour asymmetries\n* skin irregularities\n* cellulite\n* Willingness and ability to comply with all study visits and procedures.\n* Sufficient predisposition and capacity, in the investigator's judgment, to complete study questionnaires.\n* Negative urine pregnancy test for women of childbearing potential at required visits.\n* Use of appropriate contraception for women of childbearing potential, as outlined in the protocol.\n\nExclusion Criteria:\n\n* Allergy or sensitivity to any of the components of the investigational product.\n* Planned pregnancy or breastfeeding.\n* Presence of active pathology or bacterial, fungal, or viral infection in or near the area to be treated, or undergoing active treatment for these conditions\n* Presence of clinical signs of inflammation in or near the area of interest or undergoing active treatment for these conditions.\n* Individuals with a known tendency to develop hypertrophic scars or keloids.\n* Individuals undergoing anticoagulant therapy.\n* Presence of volumetric defects that are too large and require surgical procedures, in the opinion of the healthcare specialist.\n* Subjects who have undergone any interventional cosmetic procedure in the 6 months prior to entering the study or during the study, such as laser, radiofrequency, electrotherapy, intradermal fillers, lipotransfer, thread lifts, platelet-rich plasma, among others.\n* Subjects with disproportionate expectations regarding the expected results of treatment.\n* Subjects with any of the following contraindications: Chronic conditions (Active autoimmune diseases (or under immunosuppressive treatment): Systemic lupus erythematosus, scleroderma, active rheumatoid arthritis, or Sjögren's syndrome; Active infections or inflammatory processes in the area of application: Herpes simplex, pustular acne, folliculitis, or cellulitis; Uncontrolled coagulation disorders or use of anticoagulants; Immunocompromised patients (due to disease or treatment): Uncontrolled HIV, chemotherapy, systemic corticosteroids, or organ transplantation) and medications (medications that increase the risk of bleeding or bruising: anticoagulants (warfarin or acenocoumarol) and antiplatelet agents (salicylic acid, prasugrel, or ticagrelor), immunosuppressants and biologics (prolonged systemic corticosteroids such as methotrexate, azathioprine, cyclosporine, mycophenolate mofetil, biologic drugs such as infliximab or adalimumab), systemic retinoids (isotretinoin), antidepressants, oral antidiabetics/insulin)"}, 'identificationModule': {'nctId': 'NCT07441135', 'briefTitle': 'Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.', 'organization': {'class': 'INDUSTRY', 'fullName': 'i+Med S.Coop.'}, 'officialTitle': 'Efficacy and Safety of BtH Body 2.2% (Injectable Hyaluronic Acid) in Volumizing and Contouring Large Areas of the Body: Prospective Clinical Investigation.', 'orgStudyIdInfo': {'id': 'BtHCb-PIC01-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BtH Body 2.2% Treatment', 'description': 'Participants receive a single session of BtH Body 2.2%, a cross-linked hyaluronic acid injectable gel, administered subcutaneously to one or more large body areas (gluteal region, thighs, or abdomen). A touch-up session may be performed at the 4-week visit if clinically indicated. All participants are followed for 9 months with visits at 1, 3, 6, and 9 months post-treatment.', 'interventionNames': ['Device: BtH Body 2.2%']}], 'interventions': [{'name': 'BtH Body 2.2%', 'type': 'DEVICE', 'description': 'Participants receive a single session of BtH Body 2.2%, a sterile, cross-linked hyaluronic acid hydrogel injected subcutaneously into one or more predefined body areas - gluteal region, thighs, or abdomen - to provide volumization and aesthetic contour improvement. Injections are performed using the cannulas provided with the product, following standard subcutaneous infiltration technique. An optional touch-up may be administered at the 4-week visit if the investigator considers it clinically necessary.', 'armGroupLabels': ['BtH Body 2.2% Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28805', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'contacts': [{'name': 'Montse Ortega', 'role': 'CONTACT', 'email': 'mortega@laboratoriogoya.com', 'phone': '+34 621 125 099'}], 'facility': 'Complutense Medical Center (Virtus Group)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Josune Torrecilla', 'role': 'CONTACT', 'email': 'jtorrecilla@imasmed.com', 'phone': '+34945561134'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'i+Med S.Coop.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Dr. Goya Análisis, SL.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}