Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-27 @ 3:08 PM
Study NCT ID:
NCT06267066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009450', 'term': 'Neurodermatitis'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001624', 'term': 'Betamethasone Valerate'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Sixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2) each of 15 patients. All LSC lesions will be treated in any patient having multiple lesions.\n\nGroup 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.\n\nGroup 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.\n\nGroup B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between 2 groups regarding change in Pruritus severity scale', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 3 , Maximum value: 22 , higher scores mean a worse outcome.'}, {'measure': 'Comparison between 2 groups regarding change in Visual analogue scale', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value:0 , Maximum value: 10, higher scores mean a worse outcome.'}, {'measure': "Comparison between 2 groups regarding change in Investigator's Global Assessment.", 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.'}, {'measure': 'Comparison between 2 groups regarding change in Scaling score', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.'}, {'measure': 'Comparison between 2 groups regarding change in Erythema score', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.'}, {'measure': 'Comparison between 2 groups regarding change in Lichenification score', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.'}, {'measure': 'Comparison between 2 groups regarding change in Excoriation score', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 3, higher scores mean a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'change of depression score in both groups.', 'timeFrame': 'through study completion, an average of 5months', 'description': 'Minimum value: 0, Maximum value: 63, higher scores mean a worse outcome.'}, {'measure': "change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups", 'timeFrame': 'through study completion, an average of 5months', 'description': 'all will be measured by pg/ml'}, {'measure': "Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls", 'timeFrame': 'through study completion, an average of 5months', 'description': 'all will be measured by pg/ml'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lichen Simplex Chronicus', 'Fractional carbon dioxide laser', 'Depression', 'Interleukin 31', 'Nerve Growth Factor', 'Substance P'], 'conditions': ['Lichen Simplex Chronicus']}, 'referencesModule': {'references': [{'pmid': '40767880', 'type': 'DERIVED', 'citation': 'Esmat S, Sany I, Alieldin L, Nour Z, Azzazi Y. Fractional Carbon Dioxide Laser for Lichen Simplex Chronicus: A Randomized Controlled Trial. Dermatol Surg. 2025 Aug 6. doi: 10.1097/DSS.0000000000004809. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': "The goal of this randomized control trial is to compare the use of fractional carbon dioxide (Co2) laser to topical corticosteroids to treat lichen simplex chronicus (LSC) patients presenting to Dermatology outpatient clinic, Faculty of Medicine, Cairo University.\n\nParticipants will:\n\n* Be assessed clinically by doctor\n* Biopsies will be taken from them by doctor\n* Receive treatment as laser or topical steroids or both\n* Fill in depression questionnaire.\n\nResearchers will divide and compare groups as follows:\n\nSixty patients will be divided randomly through closed envelop technique into 2 groups (Group A and B) each of 30 patients. Group A will be subdivided into 2 groups (1 and 2). All LSC lesions will be treated in any patient having multiple lesions.\n\n* Group 1 - A: Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.\n* Group 2 - A: Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.\n* Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.\n\nto see if:\n\n1. Pruritus severity scale.\n2. Scaling, erythema, lichenification excoriation scores\n3. Visual analogue scale.\n4. Investigator's Global Assessment.\n5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)\n6. Depression\n\nimprove more in which group of patients after treatment.", 'detailedDescription': "All the patients were subjected to the following:\n\nI. Before treatment:\n\nA. Consent: An informed written consent will be signed by each patient before enrolment in the study.\n\nB. Detailed history taking :\n\n• Personal history: name, age, sex, skin type, occupation, residence, marital status, and smoking.\n\n* History of present illness: onset, course, duration of disease, precipitating factors and any medications.\n* Past history of any associated systemic or dermatological diseases.\n* Family history of any dermatological disease e.g. psoriasis, atopic dermatitis,….etc.\n* Drug history.\n\nC. Skin biopsy: Two 3 mm punch biopsies will be taken from the lesion from each patient under local anesthesia using (Lidocaine®). One for histopathology to confirm diagnosis of LSC and the other for measuring itching mediators in the lesion before treatment by enzyme-linked immunosorbent assay (ELISA)). Another biopsy will be taken from a non lesional skin from same patient for measuring itching mediators by ELISA. Biopsies for ELISA will be stored at -20 degree celsius in eppendorfs with 3 ml phosphate buffer saline (PBS) added to each eppendorf. Tissue samples with PBS will be homogenized by a grinder, then centrifuged for 20 minutes at 3000 revolutions per minute (rpm) speed, the supernatant will be removed to be added to the ELISA kit wells for Human Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)\n\nD. Clinical assessment:\n\n1. Pruritus severity scale.\n2. Scaling, erythema, lichenification excoriation scores\n3. Visual analogue scale.\n4. Investigator's Global Assessment.\n\n E. Depression assessment: Beck Depression Inventory questionnaire will be used to assess the depression in each patient .\n\n F. Therapeutic Intervention: Patients will be divided as discussed before. - Topical steroids used will be a moderate potency topical steroid.\n * Fractional carbon dioxide laser sessions for groups A (1 and 2) by laser machine.\n * Parameters of laser session: (Parameters will be adjusted according to skin type, lesion thickness and condition) Power 15 to 20 watt according to skin color. Dwell time 800 to1000 milliseconds. Spacing 600 micrometers. Stack 2\n\n II. After treatment:\n\n A. Assessment of biochemical efficacy (measuring itching mediators after treatment): After one month from the last session for group A and after one month from stoppage of steroids for group B, a skin biopsy from the plaque (from a nearby site to the former one) will be taken as discussed before for ELISA.\n\n B. Assessment of clinical efficacy by scores as discussed before.\n\n C. Depression assessment: Beck Depression Inventory questionnaire will be repeated.\n\n D. Assessment of safety:\n * Assessment of side effects of laser and their treatment:\n\n Erythema, burning sensation, PIH, pruritus and/or pixilation. • Assessment of side effects of topical corticosteroids and their treatment: Atrophy, telangiectasia, hypopigmentation, hypertrichosis, purpura, ulceration, irritation, secondary infection.\n\n • Assessment of side effects of skin biopsy and their treatment: Bleeding, secondary infection and/or Scarring."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with LSC with no underlying dermatological disease, not on topical or systemic treatment for at least 4 weeks prior to study.\n\nExclusion Criteria:\n\n* Pregnant and lactating females.\n* Patients who are diagnosed with any systemic disease that can result in generalized pruritus (e.g. hepatic, renal, uncontrolled diabetes mellitus, thyroid,….etc ) from history.\n* Patients with contraindications to laser e.g., keloidal tendency, post inflammatory hyperpigmentation (PIH).\n* Patients with dermatological disease (e.g. psoriasis, atopic dermatitis, ….etc)'}, 'identificationModule': {'nctId': 'NCT06267066', 'briefTitle': 'Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MD-232-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Corticosteroids', 'description': 'Patients will be prescribed topical steroids cream twice daily and topical emollient once daily for 3 months.', 'interventionNames': ['Drug: Betamethasone Valerate 0.1% Cream', 'Drug: Vaseline Topical Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fractional carbon dioxide', 'description': 'Patients will receive 3 monthly laser sessions, in addition to the use of topical emollients only once daily in between the sessions.', 'interventionNames': ['Device: SmartXide® fractional carbon dioxide laser', 'Drug: Vaseline Topical Product']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined topical corticosteroids and Laser', 'description': 'Patients will receive 3 monthly laser sessions, in addition to topical steroids twice daily and topical emollient once daily in between the sessions.', 'interventionNames': ['Drug: Betamethasone Valerate 0.1% Cream', 'Device: SmartXide® fractional carbon dioxide laser', 'Drug: Vaseline Topical Product']}], 'interventions': [{'name': 'Betamethasone Valerate 0.1% Cream', 'type': 'DRUG', 'description': 'Moderate potency', 'armGroupLabels': ['Combined topical corticosteroids and Laser', 'Topical Corticosteroids']}, {'name': 'SmartXide® fractional carbon dioxide laser', 'type': 'DEVICE', 'description': 'Ablative', 'armGroupLabels': ['Combined topical corticosteroids and Laser', 'Fractional carbon dioxide']}, {'name': 'Vaseline Topical Product', 'type': 'DRUG', 'description': 'Emollient', 'armGroupLabels': ['Combined topical corticosteroids and Laser', 'Fractional carbon dioxide', 'Topical Corticosteroids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Noha Asem, professor', 'role': 'CONTACT', 'email': 'kasralainirec@yahoo.com', 'phone': '01003657120', 'phoneExt': '20'}, {'name': 'Lobna Alieldin, MSc', 'role': 'CONTACT', 'email': 'Lobnaalieldin@gmail.com', 'phone': '01002279968', 'phoneExt': '20'}, {'name': 'Lobna Alieldin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lobna Alieldin', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Lobna Alieldin', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '3 months up to 12 months after publication.', 'ipdSharing': 'YES', 'description': "Participants' data that underlie reported results will be shared upon request, after deidentification, for researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal. This is beginning 3 months up to 12 months after publication.", 'accessCriteria': 'Researches who provide a methodologically sound proposal to access data to achieve aims in the approved proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Lobna Gamal Alieldin', 'investigatorAffiliation': 'Cairo University'}}}}