Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-01-05 @ 2:31 PM
Study NCT ID:
NCT06978361
Status:
RECRUITING
Last Update Posted:
2025-05-18
First Post:
2025-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Efficacy of Microneedling With Platelet Rich Plasma Vs Microneedling With Topical Insulin in the Treatment of Acne Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}, {'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2025-05-10', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of treatment', 'timeFrame': '6 months', 'description': 'Efficacy will be determined by using the Goodman and Baron\'s Scarring Grading System as" Percentage of decrease in acne scar grade" i.e calculated through subtracting post treatment grade from pre treatment grade and then multiplying it with 100 in both treatment groups .'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-acne atrophic scars', 'Microneedling with autologous Platelet- Rich Plasma', 'Microneedling with topical insulin'], 'conditions': ['Post-acne Atrophic Scars']}, 'descriptionModule': {'briefSummary': 'This study compares the outcome of two procedures for the treatment of atrophic acne scars.', 'detailedDescription': 'Post acne scars develop due to severely inflamed and nodulocystic acne. Numerous methods exist for the treatment of post acne scars including lasers , microneedling and chemical peels etc . This study is to compare the efficacy two procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients confirmed with post-acne atrophic scars . No prior treatment for scars in last 6 months.\n\n\\-\n\nExclusion Criteria:\n\n* Patient with active acne or other skin conditions (e.g eczema , psoriasis). Patients on oral or topical retinoids. Pregnant or lactating Mothers. Patients with recurrent herpes simplex infection. Previous Hx of keloids / hypertrophic scarring. Deranged blood glucose levels. Bleeding disorders'}, 'identificationModule': {'nctId': 'NCT06978361', 'briefTitle': 'Comparison of Efficacy of Microneedling With Platelet Rich Plasma Vs Microneedling With Topical Insulin in the Treatment of Acne Scars', 'organization': {'class': 'OTHER', 'fullName': 'Khyber Teaching Hospital'}, 'officialTitle': 'Comparison of Efficacy of Microneedling With Autologous Platelet-Rich Plasma vs Microneedling With Topical Insulin in the Treatment of Atrophic Acne Scars', 'orgStudyIdInfo': {'id': '938/DME/KMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A , Microneedling with autologous PRP', 'description': 'Patients in group A will undergo microneedling with autologous PRP i.e cleansing of the treatment area with an antiseptic solution will be performed.Topical anesthetic will be applied to the area for 20-30 mins .Approximately 10ml of blood will be drawn into sterile tubes. blood sample will be placed in centrifuge 10-15mins which separates the blood components, allowing for the collection of PRP .Then sterile microneedling device will be used to begin the procedure by adjusting the needle depth according to scar severity.Controlled microinjuries to the skin will be made by moving the device in a systematic pattern over the treatment area .After microneedling ,immediately harvested PRP will be applied to the treated area ,allowing it to penetrate into the microinjuries .Patient will be asked for consideration of aftercare instructions ,including avoiding sun exposure , harsh skincare products and strenuous exercise for few days.', 'interventionNames': ['Procedure: Microneedling with autologous Platelet Rich Plasma']}, {'type': 'EXPERIMENTAL', 'label': 'Group B , Microneedling with Topical insulin', 'description': 'Patients in group B will undergo microneedling with Topical insulin i.e cleansing of the treatment area with an antiseptic solution will be performed.Topical anesthetic will be applied to the area for 20-30 mins to reduce discomfort during the procedure.Then sterile microneedling device will be used to begin the procedure by adjusting the needle depth according to scar severity.Controlled microinjuries to the skin will be made by moving the device in a systematic pattern over the treatment area .After microneedling Insulin (Regular) will be applied immediately to the treated area. insulin will be allowed to penetrate into the microinjuries created by the microneedling for about 30 mins . Patient will be asked for consideration of aftercare instructions ,including avoiding sun exposure , harsh skincare products and strenuous exercise for few days.', 'interventionNames': ['Procedure: Microneedling with topical insulin']}], 'interventions': [{'name': 'Microneedling with autologous Platelet Rich Plasma', 'type': 'PROCEDURE', 'description': 'Patients in group A will undergo Microneedling with autologous PRP', 'armGroupLabels': ['Group A , Microneedling with autologous PRP']}, {'name': 'Microneedling with topical insulin', 'type': 'PROCEDURE', 'description': 'Patients in group B will undergo Microneedling with Topical insulin ( regular).', 'armGroupLabels': ['Group B , Microneedling with Topical insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'KPK ,Pakistan', 'status': 'RECRUITING', 'country': 'Pakistan', 'facility': 'Khyber Teaching Hospital', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'centralContacts': [{'name': 'Soaiba Naeem, MBBS', 'role': 'CONTACT', 'email': 'soaiba91@gmail.com', 'phone': '+923139493991'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Patient's confidentiality may be breached ."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Soaiba Naeem', 'investigatorAffiliation': 'Khyber Teaching Hospital'}}}}