Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07028567
Status:
COMPLETED
Last Update Posted:
2025-06-19
First Post:
2025-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Subcision Followed by Diluted Calcium Hydroxylapatite Injection Versus Subcision Followed by Painting CROSS TCA Technique for the Treatment of Atrophic Acne Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'One week', 'description': 'Patient satisfaction was assessed at the final follow-up visit using a 5-point Likert-type scale, comparing outcomes to the pre-treatment condition. The scale ranged from 1 (highly dissatisfied), 2 (slightly dissatisfied), 3 (neither satisfied nor dissatisfied), 4 (satisfied), to 5 (highly satisfied).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subcision', 'Calcium Hydroxylapatite', 'Trichloroacetic Acid', 'Atrophic Acne Scar']}, 'descriptionModule': {'briefSummary': 'This study aimed to compare the safety and efficacy of subcision followed by diluted calcium hydroxyapatite injection versus subcision followed by the painting original chemical reconstruction of skin scars (CROSS) technique using trichloroacetic acid (TCA) for the treatment of atrophic acne scars.', 'detailedDescription': 'Atrophic scars present as depressions secondary to fibrous contractions. Subcision is a technique in which a needle is inserted under the acne scar to sever the fibrous tissue (tethers) that bind down the scar. This releases the fibrous tissue.\n\nThe original chemical reconstruction of skin scars (CROSS) technique using trichloroacetic acid (TCA) entails focal application of highly concentrated TCA (70% to 100%) with firm pressure applied to the entire atrophic area using a sharpened wooden applicator until frosting occurs.\n\nFillers containing hyaluronic acid, calcium hydroxyapatite, and poly-L-lactic acid are increasingly used to correct atrophic acne scarring as they augment soft tissue in variable degree and are most effective in soft rolling or boxcar scars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 20 to 50 years.\n* Both sexes.\n* Patients with atrophic acne scars.\n\nExclusion Criteria:\n\n* Patients with Fitzpatrick skin phototypes V and VI.\n* Receiving systemic isotretinoin medication at the time of the study.\n* Active bacterial, viral or fungal infections in the treatment area.\n* Hypertrophic scarring or keloidal tendency.\n* Photosensitivity or photodermatitis.\n* Unrealistic expectation, bleeding, coagulation disorders, and any other related skin disease.\n* Pregnant or lactating females.\n* Chronic debilitating diseases such as diabetes mellitus, cardiovascular diseases, renal failure, hepatic diseases, chronic respiratory diseases or any endocrine diseases.\n* History of immunosuppressive drug intake or chemotherapy within 6 months before treatment.'}, 'identificationModule': {'nctId': 'NCT07028567', 'briefTitle': 'Subcision Followed by Diluted Calcium Hydroxylapatite Injection Versus Subcision Followed by Painting CROSS TCA Technique for the Treatment of Atrophic Acne Scars', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study of Subcision Followed by Diluted Calcium Hydroxylapatite Injection Versus Subcision Followed by Painting CROSS TCA Technique for the Treatment of Atrophic Acne Scars', 'orgStudyIdInfo': {'id': '36195/12/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients with atrophic acne scars.', 'interventionNames': ['Drug: Calcium hydroxylapatite filler', 'Drug: Painting chemical reconstruction of skin scars trichloroacetic acid technique']}], 'interventions': [{'name': 'Calcium hydroxylapatite filler', 'type': 'DRUG', 'description': 'Patients received calcium hydroxylapatite filler (CaHA) (Radiesse®).', 'armGroupLabels': ['Study group']}, {'name': 'Painting chemical reconstruction of skin scars trichloroacetic acid technique', 'type': 'DRUG', 'description': 'Patients received painting chemical reconstruction of skin scars (CROSS) trichloroacetic acid (TCA) technique.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Dermatology and Venereology, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Riham Mohamed ElSayed ElSetiha', 'investigatorAffiliation': 'Tanta University'}}}}