Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT02174393
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2014-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microneedling Plus the Universal Peel For Acne Scarring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097244', 'term': 'Percutaneous Collagen Induction'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-18', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-23', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in the appearance of acne scarring as measured by The Goodman and Baron Grading Scale.', 'timeFrame': '6 months', 'description': 'The scale will be completed at every office visit over the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).'}, {'measure': 'Improvement in the appearance of acne scarring as measured by the 4 Point Scar Scale.', 'timeFrame': '6 Months', 'description': 'The scale will be completed at each office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).'}, {'measure': 'Improvement in the appearance of acne scarring as measured by the Global Assessment.', 'timeFrame': '6 months', 'description': 'The Global Assessment of Improvement will be completed at Week 17.'}], 'secondaryOutcomes': [{'measure': 'Improvement in the appearance of acne scarring as subjectively measured through digital pictures.', 'timeFrame': '6 months', 'description': 'Pictures of the subject will be taken by the Principal Investigator at every office visit during the 6 month study (Baseline, Weeks 1, 3, 5, 7, 9, 11, and 17).'}, {'measure': 'Patient-reported improvement in the appearance of acne scarring as measured by the Cardiff Index.', 'timeFrame': '6 months', 'description': 'The Cardiff Index will be completed at Baseline and Week 17.'}, {'measure': 'Patient reported improvement in appearance of acne scarring a measured by pre and post-treatment questionnaires.', 'timeFrame': '6 months', 'description': 'Subject will complete a pre-treatment questionnaire at Baseline and post-treatment questionnaires at Weeks 7 and 17.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acne Scarring']}, 'descriptionModule': {'briefSummary': 'Acne is a prevalent disorder mostly witnessed in adolescents, but can be seen in adults. Early treatment is imperative to reduce acne scarring which can appear with atrophic lesions, and depending on the skin type, significant erythema (redness) or post-inflammatory hyperpigmentation. A multi-modality approach to treatment is necessary when dealing with the aforementioned types of lesions. Pharmacologic management is essential, but safe procedural therapies are also necessary specifically with darker skinned individuals.\n\nPercutaneous collagen induction therapy (PCIT) is a non-invasive treatment achieved by using a micro-needling device, which is safe and effective in causing "micro-wounds" into the dermis thereby initiating wound healing followed by collagen production. This is an ideal treatment for acne scarring, re-texturizing of the skin, and hyperpigmentation for all skin types . Currently there are very few studies evaluating the safety and efficacy of microneedling and chemical peels in skin types III-VI.\n\nThe aim of this study is to evaluate the effects of the combination of microneedling and chemical peel for the treatment of acne scars in skin types III-VI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject \\> 18 and \\< 60 years of age.\n* Subject has skin type III, IV, V, or VI as defined by the Fitzpatrick Classification Scale.\n* Subject has acne scarring as defined by the Goodman and Baron Grading System.\n\nExclusion Criteria:\n\n* Subject currently has moderate to severe acne on the face.\n* Subject has an active infection.\n* Subject is pregnant or lactating.\n* Subject has a history of a bleeding disorder.\n* Subject is taking an anti-coagulant.\n* Subject has a history of keloidal tendency.\n* Subject has received ablative or non-ablative laser treatments in the previous 6 months.\n* Subject has taken Accutane within the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT02174393', 'briefTitle': 'Microneedling Plus the Universal Peel For Acne Scarring', 'organization': {'class': 'OTHER', 'fullName': 'Englewood Hospital and Medical Center'}, 'officialTitle': 'Efficacy of Combination Therapy With Microneedling and the Universal Peel For Acne Scarring in Skin Types III-VI', 'orgStudyIdInfo': {'id': 'E-14-555'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microneedling Plus Universal Peel', 'description': '(1) Microneedling treatment by the MicroPen with a Post-Microneedling Skin Care Regimen and the (2) Universal Peel by Topix with a Post-Universal Peel Skin Care Regimen will both be performed on a monthly basis for a total of three treatment sessions each.\n\nMicroneedling will be done on Study Weeks 1, 5, and 9. Universal Peel will be done on Study Weeks 3, 7, and 11.', 'interventionNames': ['Drug: Universal Peel', 'Procedure: Microneedling', 'Drug: Post-Microneedling Skin Care', 'Drug: Post-Universal Peel Skin Care']}], 'interventions': [{'name': 'Universal Peel', 'type': 'DRUG', 'description': 'Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)', 'armGroupLabels': ['Microneedling Plus Universal Peel']}, {'name': 'Microneedling', 'type': 'PROCEDURE', 'description': 'Microneedling: is a device for all skin types that creates micro "injuries" in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin.\n\nFor this protocol, the needle depth will be increased over the 3 sessions:\n\nForehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm.\n\nEach Session: Microneedling procedure on Day 1, followed by skin care regimen', 'armGroupLabels': ['Microneedling Plus Universal Peel']}, {'name': 'Post-Microneedling Skin Care', 'type': 'DRUG', 'description': 'On Day 1 (after Microneedling procedure):\n\n* Gentle Antioxidant Soothing Cleanser daily\n* Soothing Recovery Ointment and Sheer Physical Sunscreen\n\nOn Day 2-7:\n\n* AM: Physical sheer sunscreen and recovery ointment\n* PM: Retinol/Vitamin C in the evening and soothing recovery ointment\n\nOn Day 7:\n\n* AM: BD Hydrating Day/Night Cream\n* PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary)', 'armGroupLabels': ['Microneedling Plus Universal Peel']}, {'name': 'Post-Universal Peel Skin Care', 'type': 'DRUG', 'description': '* Gentle Antioxidant Soothing Cleanser daily\n* Physical Sunscreen daily\n* Soothing recovery ointment fortified with silver only when peeling occurs\n* After completely peeling, vitamin c product in the morning and the retinol in the evening', 'armGroupLabels': ['Microneedling Plus Universal Peel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07632', 'city': 'Englewood Cliffs', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bergen Dermatology', 'geoPoint': {'lat': 40.88538, 'lon': -73.95236}}], 'overallOfficials': [{'name': 'Naana Boakye, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Englewood Hospital and Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Englewood Hospital and Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Topix Pharmaceuticals', 'class': 'UNKNOWN'}, {'name': 'Eclipse Aesthetics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}