Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT04893304
Status:
UNKNOWN
Last Update Posted:
2021-05-19
First Post:
2021-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000052', 'term': 'Acanthosis Nigricans'}], 'ancestors': [{'id': 'D008548', 'term': 'Melanosis'}, {'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054020', 'term': 'Lasers, Gas'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-18', 'studyFirstSubmitDate': '2021-04-25', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient evaluation', 'timeFrame': '3 months', 'description': 'Acanthosis nigricans area and severity index is scoring system used to assess patients before the session and after the session to assess finally the improvement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acanthosis Nigricans']}, 'descriptionModule': {'briefSummary': 'This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria.\n\n-Evaluation:\n\nAll patients will be subjected to:\n\nPre-operative preparation:\n\n* Informed written consent will be taken from every patient prior to the study.\n* Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.\n* Assessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.\n* Photography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.\n* Melanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019\n* Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.\n* Patient satisfaction score will be assessed before starting the study and two weeks after the last session.\n* Patient evaluation (clinical percentage of improvement).\n\nOperation :\n\nOne side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months.\n\nMethod of randomization:\n\nUsing closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator. Post-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.', 'detailedDescription': 'This prospective randomized comparative split study will be conducted at the outpatient clinic, Dermatology department, Faculty of Medicine, Cairo University and will include 20 patients with acanthosis nigricans in otherwise healthy individuals which will be recruited and assessed for eligibility for inclusion according to the above criteria. -Evaluation:\n\nAll patients will be subjected to the following:\n\nPre-operative preparation:\n\nInformed written consent will be taken from every patient prior to the study. Detailed history taking including onset, course, duration of the disease and occupation (sun-exposed or not), predisposing factors, history of keloid tendency, associated diseases and previous treatments.\n\nAssessment of skin type, BMI, degree of AN, HbA1C, site of lesions in all patients and degree of improvement.\n\nPhotography: will evaluate the clinical response to treatment for each patient Photos will be taken before starting the study, before every session, and two weeks after the last session.\n\nMelanin index (MI) will be measured using reflectance spectrophotometer in order to assess the degree of hyperpigmentation before starting the study and two weeks after the last session. Research Template 8 Final Version: April 2019 Acanthosis Nigricans Area and Severity Index (ANASI) score (Zaki et al., 2018) will be done for all patients before starting the study and two weeks after the last session.\n\nPatient satisfaction score will be assessed before starting the study and two weeks after the last session.\n\nPatient evaluation (clinical percentage of improvement).\n\nOperation :\n\nOne side of the affected area will be randomly assigned to fractional CO2 laser every four weeks for three months. The other side will be assigned to Q-switched Nd:YAG laser every four weeks for three months.\n\nMethod of randomization:\n\nUsing closed envelopes containing cards with fractional CO2 Rt and fractional CO2 Lt and the patient will draw one of them blindly. The assessment will be done by blinded investigator.\n\nPost-operative: Patients will be instructed to avoid sun exposure for one week after the session and regular use of sun block in between sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age more than 18 years old\n2. both genders\n3. skin type III to V\n4. controlled diabetus\n\nExclusion Criteria:\n\n1. pregnancy and lactation\n2. scarring\n3. active skin infections\n4. endocrinal disorders'}, 'identificationModule': {'nctId': 'NCT04893304', 'briefTitle': 'Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Study of the Effect of Fractional co2 Laser Versus Q Switched:NdYAG Laser in the Treatment of Acanthosis Nigricans', 'orgStudyIdInfo': {'id': 'LAS123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1 group of 20 patients doing both types of lasers on 2 sites', 'description': 'comparing both types of laser', 'interventionNames': ['Device: co2 laser']}], 'interventions': [{'name': 'co2 laser', 'type': 'DEVICE', 'otherNames': ['NdYAG laser'], 'description': 'types of laser', 'armGroupLabels': ['1 group of 20 patients doing both types of lasers on 2 sites']}]}, 'ipdSharingStatementModule': {'timeFrame': 'after finishing the paper and will be always be available', 'ipdSharing': 'YES', 'description': 'results and discussion can be shared', 'accessCriteria': 'through the pubmed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principale investigator', 'investigatorFullName': 'Aya Mohamed Fahim', 'investigatorAffiliation': 'Cairo University'}}}}