Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:53 AM
Study NCT ID:
NCT07473661
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012967', 'term': 'Sodium Dodecyl Sulfate'}], 'ancestors': [{'id': 'D007851', 'term': 'Dodecanol'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dermal Irritation Score Using the International Contact Dermatitis Research Group (ICDRG) Scale', 'timeFrame': 'During the induction phase (approximately 3 consecutive weeks)', 'description': 'Dermal irritation response following repeated epidermal exposure to SILURCLOUD Fibrous Collagen Matrix during the induction phase will be assessed using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale. Each application site will receive a single ICDRG score ranging from 0 to 4 representing overall irritation severity.'}, {'measure': 'Allergic Contact Sensitization Response to SILURCLOUD Fibrous Collagen Matrix', 'timeFrame': 'At the challenge phase (approximately 10-17 days after the last induction application)', 'description': 'Determination of allergic contact sensitization following challenge exposure to SILURCLOUD Fibrous Collagen Matrix in healthy subjects. Skin reactions at the challenge site will be graded using the International Contact Dermatitis Research Group (ICDRG) skin reaction grading scale (0-4) at approximately 24 and 72 hours after patch removal.'}], 'secondaryOutcomes': [{'measure': 'Dermal Safety Outcomes Stratified by Fitzpatrick Skin Type (I and VI)', 'timeFrame': 'Through completion of all skin assessments during the study (approximately 5-6 weeks)', 'description': 'Evaluation of dermal safety outcomes stratified by Fitzpatrick Skin Type (FST) I and VI based on ICDRG irritation and sensitization scores observed during the Human Repeat Insult Patch Test (HRIPT).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['skin irritation', 'skin sensitization', 'HRIPT', 'Fibrous Collagen Matrix'], 'conditions': ['Healthy Adult']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the skin irritation and sensitization potential of SILURCLOUD™ Fibrous Collagen Matrix in healthy adult volunteers with Fitzpatrick Skin Types I and VI. The study will also generate additional safety data to address FDA 510(k) feedback regarding representation of these skin types.\n\nThe main questions it aims to answer are:\n\nDoes SILURCLOUD™ Fibrous Collagen Matrix cause primary or cumulative skin irritation under maximized patch test conditions?\n\nDoes SILURCLOUD™ Fibrous Collagen Matrix demonstrate allergic contact sensitization potential in human subjects?\n\nParticipants will:\n\nHave patches containing the test product applied to the skin under occlusive conditions\n\nReturn for repeated patch applications during the induction phase\n\nUndergo skin evaluations using standardized scoring methods\n\nComplete a challenge phase following a rest period\n\nParticipate in re-challenge testing if clinically indicated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Male and female participants\n* Fitzpatrick Skin Types I and VI\n* Participants of any race are eligible\n* Participants of any ethnicity (Hispanic or Latino or Not Hispanic or Latino) are eligible\n* Able to read and understand English and provide written informed consent in accordance with 21 CFR Part 50\n* Able to complete a HIPAA Authorization in accordance with 45 CFR Parts 160 and 164\n* In general good health and free of dermatological or systemic disorders that could interfere with study results, in the opinion of the investigator\n* Able and willing to cooperate with the investigator and clinical staff and comply with study procedures\n* Willing to have test products applied in accordance with the study protocol and able to complete the full course of the study\n* Has not participated in a similar clinical study within the previous 30 days\n* Agrees to refrain from sun tanning, sunbathing, or prolonged outdoor sun exposure during participation in the study\n* Female participants willing to undergo urine pregnancy testing prior to study participation\n* Agrees not to change current personal care products (such as soaps, body washes, laundry detergents, body sprays, or body spritzes) during participation in the study\n\nExclusion Criteria:\n\n* Current use of medications (topical or systemic) that may mask or interfere with study results, including corticosteroids (topical or systemic except nasal steroids), NSAIDs such as ibuprofen or aspirin greater than 325 mg/day, antihistamines, or topical/oral immunosuppressive medications; participants must refrain from topical or oral anti-inflammatory medications during the study (approximately 6 weeks)\n* History of acute or chronic disease that may interfere with study participation or increase risk to the participant (e.g., systemic lupus erythematosus, rheumatoid arthritis, HIV infection)\n* Chronic skin allergies (e.g., atopic dermatitis or eczema) or treatment for skin cancer within the previous 12 months\n* Damaged or abnormal skin in the area of the test sites (e.g., sunburn, uneven skin pigmentation, tattoos, scars, excessive hair, active acne lesions, or other skin conditions that could interfere with evaluation)\n* Diabetes requiring insulin therapy\n* Any medical history or condition that, in the opinion of the investigator, could place the participant at risk or compromise the validity of the study\n* Pregnant, planning to become pregnant, or breastfeeding\n* Known hypersensitivity to cosmetics, personal care products, fragrances, or adhesives\n* Known fish allergy'}, 'identificationModule': {'nctId': 'NCT07473661', 'acronym': 'HRIPT', 'briefTitle': 'Assessment of Skin Irritation and Sensitization of SILURCLOUD Fibrous Collagen Matrix', 'organization': {'class': 'NETWORK', 'fullName': 'SerenaGroup, Inc.'}, 'officialTitle': 'Human Repeat Insult Patch Test (HRIPT): Assessment of Primary and Cumulative Skin Irritation and Skin Sensitization of a Product Under Controlled and Maximized Conditions', 'orgStudyIdInfo': {'id': 'Pro00093062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SILURCLOUD Patch Test (HRIPT) With Controls', 'description': 'Participants will undergo repeated occlusive patch applications of SILURCLOUD™ Fibrous Collagen Matrix to evaluate dermal irritation and sensitization (HRIPT). Distilled water will be applied as a negative control throughout the study, and 0.5% sodium lauryl sulfate (in distilled water) will be applied once as a positive control. Patch sites will be evaluated using the ICDRG scoring scale.', 'interventionNames': ['Device: SILURCLOUD Fibrous Collagen Matrix', 'Drug: 0.5% Sodium Lauryl Sulfate in Distilled Water', 'Drug: Glycerosaline']}], 'interventions': [{'name': 'SILURCLOUD Fibrous Collagen Matrix', 'type': 'DEVICE', 'description': 'SILURCLOUD™ Fibrous Collagen Matrix applied under occlusive patch conditions during the Human Repeat Insult Patch Test (HRIPT) to evaluate primary irritation, cumulative irritation, and dermal sensitization potential.', 'armGroupLabels': ['SILURCLOUD Patch Test (HRIPT) With Controls']}, {'name': '0.5% Sodium Lauryl Sulfate in Distilled Water', 'type': 'DRUG', 'description': '0.5% sodium lauryl sulfate in distilled water applied under occlusive patch conditions as a positive control during the induction phase of the Human Repeat Insult Patch Test (HRIPT) to confirm expected dermal reactivity.', 'armGroupLabels': ['SILURCLOUD Patch Test (HRIPT) With Controls']}, {'name': 'Glycerosaline', 'type': 'DRUG', 'description': 'Glycerosaline applied under occlusive patch conditions as the negative control during the Human Repeat Insult Patch Test (HRIPT). The control site is evaluated alongside the test product sites to confirm absence of irritation attributable to the vehicle.', 'armGroupLabels': ['SILURCLOUD Patch Test (HRIPT) With Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15146', 'city': 'Monroeville', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Serena', 'role': 'CONTACT', 'email': 'lserena@serenagroups.com', 'phone': '1-833-865-6300'}, {'name': 'Thomas Serena, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Meghan Neil, NP', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'SerenaGroup Monroeville', 'geoPoint': {'lat': 40.42118, 'lon': -79.7881}}], 'centralContacts': [{'name': 'Nicole Schrecengost, LPN', 'role': 'CONTACT', 'email': 'nschrecengost@serenagroups.com', 'phone': '1-833-865-6300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The plan for sharing individual participant data (IPD) has not yet been determined. Any potential sharing of de-identified participant-level data will be evaluated by the sponsor after study completion and in accordance with applicable privacy regulations and sponsor policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SerenaGroup, Inc.', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}