protocolSection identificationModule nctId: NCT06267066, orgStudyIdInfo id: MD-232-2022, briefTitle: Fractional Carbon Dioxide Laser: A Novel Therapeutic Option for Lichen Simplex Chronicus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, 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.Participants will:* Be assessed clinically by doctor* Biopsies will be taken from them by doctor* Receive treatment as laser or topical steroids or both* Fill in depression questionnaire.Researchers will divide and compare groups as follows: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). All LSC lesions will be treated in any patient having multiple lesions.* 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.* 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.* Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months.to see if:1. Pruritus severity scale.2. Scaling, erythema, lichenification excoriation scores3. Visual analogue scale.4. Investigator's Global Assessment.5. Itching mediators (Interleukin-31, Nerve Growth Factor and Substance P assays (itching mediators)6. Depressionimprove more in which group of patients after treatment., conditionsModule conditions: Lichen Simplex Chronicus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, 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.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.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.Group B: Patients will be prescribed topical steroids twice daily and topical emollient once daily for 3 months., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Experienced dermatologist blinded to the interventions done will assess the patients' at the end of the treatment period., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Betamethasone Valerate 0.1% Cream, interventions name: SmartXide® fractional carbon dioxide laser, interventions name: Vaseline Topical Product, outcomesModule primaryOutcomes measure: Comparison between 2 groups regarding change in Pruritus severity scale, primaryOutcomes measure: Comparison between 2 groups regarding change in Visual analogue scale, primaryOutcomes measure: Comparison between 2 groups regarding change in Investigator's Global Assessment., primaryOutcomes measure: Comparison between 2 groups regarding change in Scaling score, primaryOutcomes measure: Comparison between 2 groups regarding change in Erythema score, primaryOutcomes measure: Comparison between 2 groups regarding change in Lichenification score, primaryOutcomes measure: Comparison between 2 groups regarding change in Excoriation score, secondaryOutcomes measure: change of depression score in both groups., secondaryOutcomes measure: change of itching mediators' levels (IL-31, Nerve Growth Factor and substance) between 2 groups, secondaryOutcomes measure: Comparison of itching mediator's levels in lesional, non-lesional skin and healthy controls, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lobna Alieldin, city: Cairo, zip: 11562, country: Egypt, contacts name: Noha Asem, professor, role: CONTACT, phone: 01003657120, phoneExt: 20, email: kasralainirec@yahoo.com, contacts name: Lobna Alieldin, MSc, role: CONTACT, phone: 01002279968, phoneExt: 20, email: Lobnaalieldin@gmail.com, contacts name: Lobna Alieldin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Lobna Alieldin, city: Cairo, zip: 11562, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False