Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:09 PM
Study NCT ID:
NCT07397520
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intralesional administration of 5-fluorouracil will be conducted in the periocular scar. For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the size of facial hypertrophic scars', 'timeFrame': 'From enrollment to the end of treatment at 4 weeks', 'description': 'To objectively assess baseline status and subsequent changes in facial skin, the validated photometric visual scale from Manchester, designed for evaluating scar quality, will be employed. This scale assesses six skin parameters, including coloration, contour, distortion, texture, and brightness, assigning values from 1 to 4, where 1 represents the most favorable characteristic and 4 the least desirable'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['5-FU', 'Fibrotic Scar', 'Facial Scarring'], 'conditions': ['Facial Scarring']}, 'referencesModule': {'references': [{'pmid': '8532986', 'type': 'RESULT', 'citation': 'Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.'}, {'pmid': '38256469', 'type': 'RESULT', 'citation': 'Kim S, Woo YR, Cho SH, Lee JD, Kim HS. Clinical Efficacy of 5-Fluorouracil and Bleomycin in Dermatology. J Clin Med. 2024 Jan 6;13(2):335. doi: 10.3390/jcm13020335.'}, {'pmid': '9494966', 'type': 'RESULT', 'citation': 'Tuan TL, Nichter LS. The molecular basis of keloid and hypertrophic scar formation. Mol Med Today. 1998 Jan;4(1):19-24. doi: 10.1016/S1357-4310(97)80541-2.'}, {'pmid': '16914994', 'type': 'RESULT', 'citation': 'Slemp AE, Kirschner RE. Keloids and scars: a review of keloids and scars, their pathogenesis, risk factors, and management. Curr Opin Pediatr. 2006 Aug;18(4):396-402. doi: 10.1097/01.mop.0000236389.41462.ef.'}, {'pmid': '25141117', 'type': 'RESULT', 'citation': 'Rabello FB, Souza CD, Farina Junior JA. Update on hypertrophic scar treatment. Clinics (Sao Paulo). 2014 Aug;69(8):565-73. doi: 10.6061/clinics/2014(08)11.'}, {'pmid': '3049954', 'type': 'RESULT', 'citation': 'Pinedo HM, Peters GF. Fluorouracil: biochemistry and pharmacology. J Clin Oncol. 1988 Oct;6(10):1653-64. doi: 10.1200/JCO.1988.6.10.1653.'}, {'pmid': '27180789', 'type': 'RESULT', 'citation': 'Ogawa R, Akaishi S, Kuribayashi S, Miyashita T. Keloids and Hypertrophic Scars Can Now Be Cured Completely: Recent Progress in Our Understanding of the Pathogenesis of Keloids and Hypertrophic Scars and the Most Promising Current Therapeutic Strategy. J Nippon Med Sch. 2016;83(2):46-53. doi: 10.1272/jnms.83.46.'}, {'pmid': '12724731', 'type': 'RESULT', 'citation': 'Longley DB, Harkin DP, Johnston PG. 5-fluorouracil: mechanisms of action and clinical strategies. Nat Rev Cancer. 2003 May;3(5):330-8. doi: 10.1038/nrc1074.'}, {'pmid': '29498630', 'type': 'RESULT', 'citation': 'Lee HJ, Jang YJ. Recent Understandings of Biology, Prophylaxis and Treatment Strategies for Hypertrophic Scars and Keloids. Int J Mol Sci. 2018 Mar 2;19(3):711. doi: 10.3390/ijms19030711.'}, {'pmid': '28287424', 'type': 'RESULT', 'citation': 'Ogawa R. Keloid and Hypertrophic Scars Are the Result of Chronic Inflammation in the Reticular Dermis. Int J Mol Sci. 2017 Mar 10;18(3):606. doi: 10.3390/ijms18030606.'}, {'pmid': '19116547', 'type': 'RESULT', 'citation': 'Haurani MJ, Foreman K, Yang JJ, Siddiqui A. 5-Fluorouracil treatment of problematic scars. Plast Reconstr Surg. 2009 Jan;123(1):139-148. doi: 10.1097/PRS.0b013e3181904d1b.'}, {'pmid': '18185952', 'type': 'RESULT', 'citation': 'Goldan O, Weissman O, Regev E, Haik J, Winkler E. Treatment of postdermabrasion facial hypertrophic and keloid scars with intralesional 5-Fluorouracil injections. Aesthetic Plast Surg. 2008 Mar;32(2):389-92. doi: 10.1007/s00266-007-9109-3.'}, {'pmid': '32479693', 'type': 'RESULT', 'citation': 'Limandjaja GC, Niessen FB, Scheper RJ, Gibbs S. Hypertrophic scars and keloids: Overview of the evidence and practical guide for differentiating between these abnormal scars. Exp Dermatol. 2021 Jan;30(1):146-161. doi: 10.1111/exd.14121. Epub 2020 Jul 6.'}, {'pmid': '2656050', 'type': 'RESULT', 'citation': 'Diasio RB, Harris BE. Clinical pharmacology of 5-fluorouracil. Clin Pharmacokinet. 1989 Apr;16(4):215-37. doi: 10.2165/00003088-198916040-00002.'}, {'pmid': '17576505', 'type': 'RESULT', 'citation': 'Atiyeh BS. Nonsurgical management of hypertrophic scars: evidence-based therapies, standard practices, and emerging methods. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):468-92; discussion 493-4. doi: 10.1007/s00266-006-0253-y. Epub 2007 Jun 18.'}, {'pmid': '8030742', 'type': 'RESULT', 'citation': 'Ehrlich HP, Desmouliere A, Diegelmann RF, Cohen IK, Compton CC, Garner WL, Kapanci Y, Gabbiani G. Morphological and immunochemical differences between keloid and hypertrophic scar. Am J Pathol. 1994 Jul;145(1):105-13.'}, {'pmid': '32342167', 'type': 'RESULT', 'citation': 'Jiang ZY, Liao XC, Liu MZ, Fu ZH, Min DH, Yu XT, Guo GH. Efficacy and Safety of Intralesional Triamcinolone Versus Combination of Triamcinolone with 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Systematic Review and Meta-analysis. Aesthetic Plast Surg. 2020 Oct;44(5):1859-1868. doi: 10.1007/s00266-020-01721-2. Epub 2020 Apr 27.'}, {'pmid': '27105629', 'type': 'RESULT', 'citation': 'Shah VV, Aldahan AS, Mlacker S, Alsaidan M, Samarkandy S, Nouri K. 5-Fluorouracil in the Treatment of Keloids and Hypertrophic Scars: A Comprehensive Review of the Literature. Dermatol Ther (Heidelb). 2016 Jun;6(2):169-83. doi: 10.1007/s13555-016-0118-5. Epub 2016 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of intralesional 5-fluorouracil in objectively reversing hypertrophic scars in the periocular region resulting from trauma or cosmetic surgery.', 'detailedDescription': 'During the initial visit, informed consent will be obtained and documented, alongside baseline photographs and measurements of the facial scar dimensions using a ruler. In the subsequent visits-second, third, fourth, and fifth-0.5 ml of intralesional 5-fluorouracil, diluted to 25 mg/ml, will be administered. Clinical photographs will be captured, and dimensions will be measured at each of these visits. A total of 0.5 ml of this solution will be injected weekly into the lesion to be treated, amounting to four doses over the course of one month.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants aged ≥18 years.\n* Presence of a facial scar in the periocular region secondary to trauma or facial cosmetic surgery.\n* Ability and willingness to provide written informed consent.\n* Signed informed consent form prior to participation.\n\nExclusion Criteria:\n\n* Presence of active local infection in the periocular region.\n* Active inflammatory dermatologic or ocular disorders in the treatment area.\n* Known allergy or hypersensitivity to 5-fluorouracil.\n* Pregnancy or breastfeeding.\n* Inability to comply with follow-up visits.\n* Withdrawal of consent during the study.\n* Development of significant local or systemic adverse reactions during the study period.'}, 'identificationModule': {'nctId': 'NCT07397520', 'acronym': 'AI5FMHFSPRFSOE', 'briefTitle': 'The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Oftalmología Fundación Conde de Valenciana'}, 'officialTitle': 'The Application of Intralesional 5-fluorouracil for the Management of Hypertrophic Facial Scars in the Periocular Region Resulting From Trauma and Surgical Procedures in Individuals Aged Over 18 Years', 'orgStudyIdInfo': {'id': 'CEI-2025/07/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intralesional administration of 5-fluorouracil will be conducted in the periocular scar group', 'description': 'For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable.', 'interventionNames': ['Drug: Intralesional administration of 5-fluorouracil']}], 'interventions': [{'name': 'Intralesional administration of 5-fluorouracil', 'type': 'DRUG', 'description': 'For the objective assessment of baseline status and subsequent facial skin changes, the validated Manchester Scar Scale will be used, which is a visual photonumeric scale for evaluating scar quality. This scale assesses six skin parameters, such as color, contour, distortion, texture, and brightness, assigning values from 1 to 4, with 1 indicating the best characteristic and 4 the least desirable', 'armGroupLabels': ['Intralesional administration of 5-fluorouracil will be conducted in the periocular scar group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Diego A Herrera Alvarado MD, Medical Doctor', 'role': 'CONTACT', 'email': 'diegoalvarado95@hotmail.com', 'phone': '+52 55 5403 1962'}], 'facility': 'Instituto de Oftalmologia F.A.P. Conde de Valenciana, I.A.P.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Diego A Alvarado Herrera MD, Medical Doctor', 'role': 'CONTACT', 'email': 'diegoalvarado95@hotmail.com', 'phone': '+52 55 5403 1962'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From November to December 2026', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Oftalmología Fundación Conde de Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}