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IRCT20230816059168N2 IRCT 2024-03-03 National University of Medical Sciences Fractional Carbon dioxide LASER with Topical Methotrexate Vs Topical PUVASOL in Treatment of Vitiligo Effectiveness Of Fractional Carbon dioxide LASER with Topical Methotrexate Vs Topical PUVASOL in Treatment of Vitiligo-RCT 2024-03-01 anticipated 30 Complete https://irct.ir/trial/75706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used to divide the study sample into two groups .Unit of randomization will be individual with the help of giving random sealed envelope to the patients. Allocation concealment will be carried out, Blinding description: Besides principal investigator and her assistant, no one in the study i.e. Patients or the neutral assessor will know about the treatment modality used. 2 Vitiligo. Intervention 1: Intervention group1: Fractional Carbon dioxide laser followed by topical methotrexate. Topical eutectic mixture of local anesthetic cream will be applied over the patient’s lesions for 30- 45 min. A 10,600-nm fractional carbon dioxide (CO2) laser device will be used. Key laser parameters included will be; a resurfacing mode, pulse energy of 70–100 J/cm2, coverage and a spot density of 150 spots/cm2 (static mode). After each session topical 25mg/ml methotrexate injection, not more than 0.3 ml will be massaged on the treated area and allowed to air dry. Patient will be given methotrexate to apply as few drops on the affected area once daily for 3 days after procedure. 4 sessions were done at 2weeks a part. Patients will be examined monthly for 2 months for assessment of re-pigmentation. Intervention 2: Intervention group 2: Topical PUVASOL. People in this Group will be advised topical psoralen with the name of Lukodermine by Howards Pharma. The ointment contains Methoxsalen as its active ingredient and comes in a pack size of 30gm .5% ointment is to be applied for 45 minutes on the vitiligous patch prior to sunlight exposure. Initially photo exposure will be done for 3 minutes and then incrementally increased by 30 seconds every time until a moderate persistent erythema or maximal exposure time of 10 minutes will be achieved. This treatment will be done thrice a week. Treated area will be washed with soap and water and sunscreen will be applied with the spf of 60 or more. Patients will be examined monthly for 2 months for assessment of re-pigmentation. Yes - There is a plan to make this available What will be shared: EFFECTIVENESS OF FRACTIONAL CARBONDIOXIDE LASER WITH TOPICAL METHOTREXATE VS TOPICAL PUVASOL IN TREATEMENT OF VITILIGO-RCT When: After publication and will be available through research gate indefinitely To whom: It will be open access. Conditions: Will depend on publishing jiurnal policy Where to obtain: Research gate, Journals website How to obtain: Sharing of complete article request Comments:
public Sakina Sadiq Malik
Saddar,Rawalpindi
Rawalpindi Pakistan 44000 +92 321 5108737 dazzlingdocsak2078@hotmail.com NUMS-Pakistan scientific Sakina Sadiq Malik
Saddar,Rawalpindi
Rawalpindi Pakistan 44000 +92 321 5108737 dazzlingdocsak2078@hotmail.com NUMS-Pakistan Pakistan Patients willing to participate in the study Patients of age group 10 -70 years. Vitiligo involving less than or equal to 10% body surface area. 10 years 70 years Both Patients using or have used other treatments for vitiligo in the recent past Pregnant women or lactating women Patients with segmental vitiligo Patients on immunosuppressant medications due to other diseases Patients having connective tissue diseases, epilepsy or photosensitivity disorders Patient having previous radiotherapy or phototherapy. Patients with personal or family history of melanoma and non-melanoma skin cancers Patients having contraindications to methotrexate or PUVASOL therapy L80 Vitiligo Treatment - Other Treatment - Drugs Intervention group1: Fractional Carbon dioxide laser followed by topical methotrexate. Topical eutectic mixture of local anesthetic cream will be applied over the patient’s lesions for 30- 45 min. A 10,600-nm fractional carbon dioxide (CO2) laser device will be used. Key laser parameters included will be; a resurfacing mode, pulse energy of 70–100 J/cm2, coverage and a spot density of 150 spots/cm2 (static mode). After each session topical 25mg/ml methotrexate injection, not more than 0.3 ml will be massaged on the treated area and allowed to air dry. Patient will be given methotrexate to apply as few drops on the affected area once daily for 3 days after procedure. 4 sessions were done at 2weeks a part. Patients will be examined monthly for 2 months for assessment of re-pigmentation. Intervention group 2: Topical PUVASOL. People in this Group will be advised topical psoralen with the name of Lukodermine by Howards Pharma. The ointment contains Methoxsalen as its active ingredient and comes in a pack size of 30gm .5% ointment is to be applied for 45 minutes on the vitiligous patch prior to sunlight exposure. Initially photo exposure will be done for 3 minutes and then incrementally increased by 30 seconds every time until a moderate persistent erythema or maximal exposure time of 10 minutes will be achieved. This treatment will be done thrice a week. Treated area will be washed with soap and water and sunscreen will be applied with the spf of 60 or more. Patients will be examined monthly for 2 months for assessment of re-pigmentation. Clinical improvement. Timepoint: At the end of 1st and 2nd month. Method of measurement: A blinded independent medical observer will perform clinical assessments using the following grading scale for all 30 patients: 1, < 25% minimal re-pigmentation; 2, 26–50% mild re-pigmentation; 3, 51–75% moderate re-pigmentation; 4, >75% excellent re-pigmentation. Patient satisfaction. Timepoint: At the end of 1st and 2nd month. Method of measurement: Patient satisfaction will also be assessed by grading scale i.e. 1. Unsatisfied, 2. Partially satisfied, 3. Completely satisfied. Self Approved 2024-02-21 Ethical commitee Pak Emirates Hospital Rawalpindi Saddar,Rawalpindi Rawalpindi Punjab Pakistan