Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT07085520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069448', 'term': 'Denosumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-12', 'size': 315768, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-15T19:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of both local and systemic Adverse Events', 'timeFrame': '2 weeks', 'description': "An adverse event is any adverse change from the subject's baseline condition, i.e. any subjective signs and symptoms, or change in a concomitant disease present at the screening visit. This includes inter-current signs, symptoms, illness and significant deviations from baseline which may occur during the course of the clinical study, whether considered related to treatment or not."}], 'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Reactions', 'timeFrame': 'Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.', 'description': 'Evaluate through skin response sheets: erythema, pain, swelling, etc.'}, {'measure': 'Amount of pain', 'timeFrame': 'Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.', 'description': 'Pain will be measured using the faces pain scales revised (0-2-4-6-8-10, 0: no pain, 10: very much pain).'}, {'measure': 'Number of injection site reactions', 'timeFrame': 'Assessed at 15 minutes, 24 hours, 48 hours, and 2 weeks post-application.', 'description': 'Injection site assessment for the following:\n\nPain (grade 1/2/3) Tenderness (grade 1/2/3) Pruritus (grade 1/2/3) Erythema (absent/present) Induration (grade 1/2/3) Blister (absent/present) Ulceration (absent/present) Necrosis (absent/present) Ecchymosis (absent/present) If any of these signs or symptoms is present, it is regarded an injection site reaction.'}], 'secondaryOutcomes': [{'measure': 'Soluble Denosumab Microneedle Patch Subject Satisfaction Questionnaire', 'timeFrame': 'Assessed at 2 weeks post-application.', 'description': 'Assessed through questionnaires at the end of the study.\n\n1. How satisfied are you with the application process of the microneedle patch?\n2. How satisfied are you with the overall skin condition around the knee after using the microneedle patch?\n3. Overall, how satisfied are you with the ease of using the microneedle patch?\n4. Overall, now that you have tried this microneedle patch and completed the study, how likely are you to use this treatment again in the future?\n5. Overall, how likely are you to recommend this microneedle patch treatment to a family member or friend? 5 = Very Likely; 4 = Somewhat Likely; 3 = Neutral; 2 = Somewhat Unlikely; 1 = Very Unlikely'}, {'measure': 'Number of participants with abnormal laboratory tests results', 'timeFrame': 'Assessed at 2 weeks post-application.', 'description': "Evaluation of blood routine and blood electrolytes to monitor participants' health status and safety."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Osteoarthritis (OA) of the Knee', 'Osteoporosis', 'Osteoporosis (Senile)', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the skin safety of a soluble denosumab microneedle patch in participants with osteoporosis and osteoarthritis. The main questions it aims to answer are:\n\n* Is the soluble denosumab microneedle patch safe for use on the skin?\n* What are the potential skin reactions to the patch?\n\nResearchers will compare different doses of the microneedle patch to assess its safety.\n\nParticipants will:\n\n* Apply the microneedle patch to four different areas around their knee\n* Undergo skin assessments at various time points after application\n* Be monitored for any adverse skin reactions\n\nThe study will take place at a single center and involve a small number of participants to provide preliminary data on the safety of this novel drug delivery system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed and dated informed consent.\n2. Commitment to comply with the study protocol and cooperate throughout the study.\n3. Age 18-70, healthy or adult male or female with osteoarthritis combined with osteoporosis.\n4. No history of skin diseases or other underlying conditions.\n5. No antihistamines, vasodilators, vasoconstrictors, anticoagulants, hormones, or immunosuppressants within the past month.\n6. If of childbearing age, women must have used contraception for at least one month before screening and commit to using contraception throughout the study period and for a specified time after the study ends.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Smoking \\>10 cigarettes per day or smoking history \\>20 years.\n3. Presence of conditions that may interfere with the study results (e.g., severe diseases, infectious diseases, allergies, etc.) or relevant medical history.\n4. Individuals receiving systemic or local treatments that affect skin homeostasis.\n5. Allergic or intolerant to polyvinylpyrrolidone (PVP) or polyvinyl alcohol (PVA).\n6. Contraindications for denosumab (e.g., hypocalcemia).'}, 'identificationModule': {'nctId': 'NCT07085520', 'acronym': 'CSEDSSDMP', 'briefTitle': 'A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches', 'orgStudyIdInfo': {'id': '20250379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Microneedle with Saline', 'description': 'This study arm uses microneedle patches loaded with saline as a control to assess the skin safety of the microneedle patches. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'interventionNames': ['Drug: Saline Microneedle Patch']}, {'type': 'EXPERIMENTAL', 'label': 'Microneedle with 0.24mg Denosumab', 'description': 'This study arm uses microneedle patches loaded with 0.24mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'interventionNames': ['Drug: Microneedle with 0.24mg Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Microneedle with 1.2mg Denosumab', 'description': 'This study arm uses microneedle patches loaded with 1.2mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'interventionNames': ['Drug: Microneedle with 1.2mg Denosumab']}, {'type': 'EXPERIMENTAL', 'label': 'Microneedle with 6mg Denosumab', 'description': 'This study arm uses microneedle patches loaded with 6mg of denosumab to evaluate the skin safety and tolerability of the microneedle patch. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'interventionNames': ['Drug: Microneedle with 6mg Denosumab']}], 'interventions': [{'name': 'Microneedle with 0.24mg Denosumab', 'type': 'DRUG', 'otherNames': ['Soluble Denosumab Microneedle Patch'], 'description': 'This intervention uses microneedle patches loaded with 0.24mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'armGroupLabels': ['Microneedle with 0.24mg Denosumab']}, {'name': 'Saline Microneedle Patch', 'type': 'DRUG', 'description': 'This intervention involves the use of a microneedle patch loaded with saline. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It serves as a control to assess the skin safety of the microneedle patch without the active drug. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'armGroupLabels': ['Microneedle with Saline']}, {'name': 'Microneedle with 1.2mg Denosumab', 'type': 'DRUG', 'description': 'This intervention uses microneedle patches loaded with 1.2mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'armGroupLabels': ['Microneedle with 1.2mg Denosumab']}, {'name': 'Microneedle with 6mg Denosumab', 'type': 'DRUG', 'description': 'This intervention uses microneedle patches loaded with 6mg of denosumab. The patch is made of a biocompatible material, polyvinyl pyrrolidone (PVP), and is applied to the skin around the knee. It aims to evaluate the skin safety and tolerability of the microneedle patch at this specific dose. Participants will apply 4 microneedle patches around their knee and avoid behaviors that may affect skin condition during the study.', 'armGroupLabels': ['Microneedle with 6mg Denosumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Wei Tong', 'role': 'CONTACT', 'email': 'tongwei312@hust.edu.cn', 'phone': '86 13437105155'}], 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Wei Tong', 'role': 'CONTACT', 'email': 'tongwei312@hust.edu.cn', 'phone': '86 13437105155'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}