Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
Study NCT ID:
NCT04419350
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2020-05-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microneedling for Acquired Hypomelanosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D017496', 'term': 'Hypopigmentation'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D014820', 'term': 'Vitiligo'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* The area to be treated will be specified and split into two halves then randomized using sealed envelope into one of both arms: treatment or no treatment.\n* One session of microneedling using derma roller 1.5 mm will be done.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2020-05-23', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of microneedling for acquired hypomelanosis assessed by skin mapping for peripheral tanning.', 'timeFrame': '3 months post treatment', 'description': "drawing the lesion's surface area through transparent stencil paper"}, {'measure': 'Efficacy of microneedling for acquired hypomelanosis assessed by visual analogue scale for surface tanning', 'timeFrame': '3 months post treatment', 'description': 'using hue skin tone color scale'}, {'measure': 'Efficacy of microneedling for acquired hypomelanosis assessed by vitiligo extent score for a target area for marginal and perifollicular repigmentation.', 'timeFrame': '3 months post treatment', 'description': 'The repigmentation assessed by percentage value range from 0- 100% where the 100 % means full repigmentation, the value is a result of an equation where the estimated percentage of marginal repigmentation add to ( remaining area (%) plus estimated percent of perifollicular pigmentation in the remaining area(%) divided by 100)'}, {'measure': "Efficacy of microneedling for acquired hypomelanosis assessed by the patient's satisfaction score", 'timeFrame': '3 months post treatment', 'description': '3-point scale (not satisfied, moderately satisfied, extremely satisfied).'}, {'measure': 'Efficacy of microneedling for acquired hypomelanosis assessed by patient global percent of his own improvement(0-100%).', 'timeFrame': '3 months post treatment', 'description': 'the patient evaluation to lesion by percentage value for repigmentation ranged from 0- 100% which represent full repigmentation.'}, {'measure': "Efficacy of microneedling for acquired hypomelanosis assessed by mean physician's global assessment for percent of improvement (0-100%).", 'timeFrame': '3 moonths post treatment.', 'description': 'One unblinded and 2 blinded investigators assessed the global improvement through photographs of the lesions before and after 3 months of therapy. The lesions were photographed on a black background using a single reflex camera with standardized settings (ambient light, same position, and distance from the patient).'}], 'secondaryOutcomes': [{'measure': 'Incidence of microneedling adverse events', 'timeFrame': 'Day 1 to 14 and after 3 months.', 'description': 'Safety as defined by occurrence of pain, bleeding, local infection, skin flaking, and scarring during, shortly after the procedure (2weeks), and at the end of the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microneedling', 'Dermaroller', 'acquired hypomelanosis', 'skin pigmentation', 'hypopigmentation', 'patient satisfaction', 'leukoderma'], 'conditions': ['Acquired Hypomelanosis']}, 'referencesModule': {'references': [{'pmid': '9429023', 'type': 'BACKGROUND', 'citation': 'Zeitlin RE. Long-term psychosocial sequelae of paediatric burns. Burns. 1997 Sep;23(6):467-72. doi: 10.1016/s0305-4179(97)00045-4.'}, {'pmid': '9313126', 'type': 'BACKGROUND', 'citation': 'Tyack ZF, Pegg S, Ziviani J. Postburn dyspigmentation: its assessment, management, and relationship to scarring--a review of the literature. J Burn Care Rehabil. 1997 Sep-Oct;18(5):435-40. doi: 10.1097/00004630-199709000-00012.'}, {'pmid': '1807141', 'type': 'BACKGROUND', 'citation': 'Sperry K. Tattoos and tattooing. Part I: History and methodology. Am J Forensic Med Pathol. 1991 Dec;12(4):313-9. doi: 10.1097/00000433-199112000-00008.'}, {'pmid': '27559496', 'type': 'BACKGROUND', 'citation': 'Singh A, Yadav S. Microneedling: Advances and widening horizons. Indian Dermatol Online J. 2016 Jul-Aug;7(4):244-54. doi: 10.4103/2229-5178.185468.'}, {'pmid': '26288404', 'type': 'BACKGROUND', 'citation': 'Siadat AH, Rezaei R, Asilian A, Abtahi-Naeini B, Rakhshanpour M, Raei M, Hosseini SM. Repigmentation of Hypopigmented Scars Using Combination of Fractionated Carbon Dioxide Laser with Topical Latanoprost Vs. Fractionated Carbon Dioxide Laser Alone. Indian J Dermatol. 2015 Jul-Aug;60(4):364-8. doi: 10.4103/0019-5154.160481.'}, {'pmid': '8909758', 'type': 'BACKGROUND', 'citation': 'Kahn AM, Cohen MJ. Treatment for depigmentation following burn injuries. Burns. 1996 Nov;22(7):552-4. doi: 10.1016/0305-4179(96)88885-1.'}, {'pmid': '15016298', 'type': 'BACKGROUND', 'citation': 'Imokawa G. Autocrine and paracrine regulation of melanocytes in human skin and in pigmentary disorders. Pigment Cell Res. 2004 Apr;17(2):96-110. doi: 10.1111/j.1600-0749.2003.00126.x.'}, {'pmid': '27755171', 'type': 'BACKGROUND', 'citation': 'Hou A, Cohen B, Haimovic A, Elbuluk N. Microneedling: A Comprehensive Review. Dermatol Surg. 2017 Mar;43(3):321-339. doi: 10.1097/DSS.0000000000000924.'}, {'pmid': '17338685', 'type': 'BACKGROUND', 'citation': 'Glaich AS, Rahman Z, Goldberg LH, Friedman PM. Fractional resurfacing for the treatment of hypopigmented scars: a pilot study. Dermatol Surg. 2007 Mar;33(3):289-94; discussion 293-4. doi: 10.1111/j.1524-4725.2007.33058.x.'}, {'pmid': '21198879', 'type': 'BACKGROUND', 'citation': 'Cho S, Zheng Z, Park YK, Roh MR. The 308-nm excimer laser: a promising device for the treatment of childhood vitiligo. Photodermatol Photoimmunol Photomed. 2011 Feb;27(1):24-9. doi: 10.1111/j.1600-0781.2010.00558.x.'}, {'pmid': '23162241', 'type': 'BACKGROUND', 'citation': 'Chadwick S, Heath R, Shah M. Abnormal pigmentation within cutaneous scars: A complication of wound healing. Indian J Plast Surg. 2012 May;45(2):403-11. doi: 10.4103/0970-0358.101328.'}, {'pmid': '27156803', 'type': 'BACKGROUND', 'citation': 'Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (ReNovaCell) for repigmentation of hypopigmented burn scars. Burns. 2016 Nov;42(7):1556-1566. doi: 10.1016/j.burns.2016.04.009. Epub 2016 May 4.'}, {'pmid': '28149233', 'type': 'BACKGROUND', 'citation': 'Busch KH, Bender R, Walezko N, Aziz H, Altintas MA, Aust MC. Combination of medical needling and non-cultured autologous skin cell transplantation (renovacell) for repigmentation of hypopigmented burn scars in children and young people. Ann Burns Fire Disasters. 2016 Jun 30;29(2):116-122.'}, {'pmid': '18349665', 'type': 'BACKGROUND', 'citation': 'Aust MC, Fernandes D, Kolokythas P, Kaplan HM, Vogt PM. Percutaneous collagen induction therapy: an alternative treatment for scars, wrinkles, and skin laxity. Plast Reconstr Surg. 2008 Apr;121(4):1421-1429. doi: 10.1097/01.prs.0000304612.72899.02.'}, {'pmid': '15313811', 'type': 'BACKGROUND', 'citation': 'Alexiades-Armenakas MR, Bernstein LJ, Friedman PM, Geronemus RG. The safety and efficacy of the 308-nm excimer laser for pigment correction of hypopigmented scars and striae alba. Arch Dermatol. 2004 Aug;140(8):955-60. doi: 10.1001/archderm.140.8.955.'}, {'pmid': '10839394', 'type': 'BACKGROUND', 'citation': 'Acikel C, Ulkur E, Guler MM. Treatment of burn scar depigmentation by carbon dioxide laser-assisted dermabrasion and thin skin grafting. Plast Reconstr Surg. 2000 May;105(6):1973-8. doi: 10.1097/00006534-200005000-00009.'}, {'pmid': '39584682', 'type': 'DERIVED', 'citation': 'Elhoshy K, Ibrahim J, Hafez V. Microneedling in Localized Acquired Hypomelanosis: A Randomized Controlled Trial. Dermatol Surg. 2025 Mar 1;51(3):257-262. doi: 10.1097/DSS.0000000000004447. Epub 2024 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'Acquired hypomelanosis is a type of cutaneous melanocytopenic hypomelanosis, denoting the lightening of the skin due to a reduction in the number of epidermal and/or follicular melanocytes secondary to physical agents,post-inflammatory, and iatrogenic (steroids).\n\nDerma roller is the basic device of microneedling , performs superficial, controlled puncturing of the skin by rolling with miniature fine needles and used as a collagen induction therapy and a transdermal delivery system for therapeutic drugs and vaccines.\n\nThis minute trauma to the skin that activates regenerative mechanisms and wound healing by releasing growth factors. The release of cytokines and deposition of hemosiderin from dermal bleeding induce the activation of melanocyte and stimulate skin pigmentation plus transdermal traveling of melanocyte', 'detailedDescription': "The aim of this study to evaluate the efficacy and safety of microneedling as a treatment model for patients with acquired hypomelanosis.\n\nPatients with an acquired hypomelanosis from outpatient clinic, department of dermatology, Cairo university,n=20. including:\n\nâ–ŞPatients, both genders and older than 18 years with localized acquired hypomelanosis\n\nExcluding:\n\n* Congenital and hereditary hypomelanosis.\n* Vitiligo\n* Pregnancy and lactation.\n* Patients with a history of any autoimmune disease.\n* Patients with a history of keloid formation.\n* Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.\n\nMethodology in details:\n\n* An informed written consent will be obtained from the patient or his legal guardian if he is younger than 21years old.\n* For every patient detailed history will focus on the onset, course, duration of hypomelanosis, the type of insult, previous treatments, systemic illness and drug history. The examination will describe the anatomical site, size, degree of skin lightening, skin texture and presence or absence of hair in the affected area.\n* The area to be treated will be specified and split into two halves then randomized into one of both arms: treatment or no treatment.\n* One session of microneedling will be performed on the treatment arm by using dermaroller 1.5 mm long. The microneedling will be done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).\n* Patients will be then monitored for three months for signs of repigmentation.\n* Patient's improvement will be objectively assessed monthly for repigmentation using patient's and physician's scales.\n\nPossible Risk:\n\nPain, transient bleeding, erythema, mild edema and infection at the site of microneedling. Failure of treatment is also a possibility.\n\nPrimary outcomes:\n\nEfficacy of microneedling for acquired hypomelanosis after 3 months.\n\nSecondary outcome:\n\nSafety as defined by the occurrence of adverse events during, shortly after the procedure (2weeks), and after 3 months.\n\nSample size(number of patients included):20 patients\n\nSource of funding: self funding"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localized acquired hypomelanosis secondary to any insult, post-inflammatory or iatrogenic of no more than 2 years duration, affecting any anatomical site except genitalia, of any size larger than 3 cm in diameter.\n* Patients older than 18 years old, consenting to go through the microneedling procedure.\n* Both genders.\n\nExclusion criteria:\n\n* Congenital and hereditary hypomelanosis.\n* Vitiligo\n* Pregnancy and lactation.\n* Patients with history of any autoimmune disease.\n* Patients with history of keloids formation.\n* Patient on systemic steroids, retinoids, immunosuppressant or anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT04419350', 'briefTitle': 'Microneedling for Acquired Hypomelanosis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Microneedling for Acquired Hypomelanosis : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MN for acquired hypomelanosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment', 'description': 'microneedling.', 'interventionNames': ['Procedure: Microneedling']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment', 'description': 'No treatment will be done to these hypopigmented lesions'}], 'interventions': [{'name': 'Microneedling', 'type': 'PROCEDURE', 'description': 'One session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).', 'armGroupLabels': ['treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35855', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khaled H El-Hoshy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Dermatology,Cairo University'}, {'name': 'Vanessa G Hafez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Dermatology, Cairo University'}, {'name': 'Julbahar M Ibrahim, M.B.,B.CH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Resident'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatology resident,Principal investigator-Cairo university.', 'investigatorFullName': 'Julbahar Ibrahim', 'investigatorAffiliation': 'Cairo University'}}}}