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IRCT20231104059946N1 IRCT 2025-05-08 Iran University of Medical Sciences Combined Laser Modalities for the Treatment of Macular Amyloidosis Evaluation of the Efficacy, Safety, Satisfaction, Tolerability, and Durability of Q-Switched Nd:YAG 1064 nm Laser in Combination with co2 Laser and Each Laser Alone in the Treatment of Macular Amyloidosis in Patients Undergoing Modified Klignman’s Formula Therapy: A Randomized, Four-Arm, Split-Face, Assessor-Blinded Clinical Trial 2024-02-15 anticipated 15 Complete https://irct.ir/trial/75511 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Blinding description: Due to the significant differences between the mentioned therapeutic interventions, blinding of the patient and the treating physician was not feasible. Therefore, the study will be conducted in a single-blind manner. In other words, outcome assessments will be performed by an evaluator blinded to the type of intervention (a dermatologist unaware of which treatment was administered to specific areas of the patient’s skin), based on standardized photographs of the lesions taken at each session. Additionally, data analysis will be conducted by a blinded statistician. N/A Macular amyloidosis. Intervention 1: Intervention Group: Fractional Q-Switched Laser Group (Zone 1). Intervention 2: Intervention Group: co2 Laser Group (Zone 2). Intervention 3: Intervention Group: Combined Fractional Q-Switched Nd:YAG and co2 Laser Therapy (Zone 3). Intervention 4: Control Group: Topical Kligman's Formula Therapy. Yes - There is a plan to make this available What will be shared: Study data will be made publicly available after analysis and de-identification of participants as part of the outcome publication. When: Following publication of the clinical trial results in international journals, the research data will become accessible To whom: All researchers at medical science universities are permitted to access the study data. Conditions: All researchers are permitted to use the data or documentation provided that they properly acknowledge the original authors. Where to obtain: Researchers may contact Dr. Paria Jafary at the following email address to request related documentation: p.jafary74@gmail.com How to obtain: All requested documentation will be provided to applicants within a maximum period of one month, subject to compliance with the stated conditions. Comments:
public Dr. Paria Jafary
Nikraveshfard St, Shadmehr St, Sattarkhan
Tehran Iran (Islamic Republic of) 1456744319 +98 21 6605 2155 p.jafary74@gmail.com Iran University of Medical Sciences scientific Dr. paria jafary
Nikraveshfard St, Shadmehr St, Sattarkhan Ave
Tehran Iran (Islamic Republic of) 1456744319 +98 21 6605 2155 p.jafary74@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Female patients aged 18 to 50 years Confirmed diagnosis of macular amyloidosis No prior laser treatment for the condition within the last three months Absence of significant underlying medical conditions Patient compliance with treatment protocols and ability to attend all therapy sessions Non-pregnant status and no plans for pregnancy within the next six months No active infections No hypersensitivity to retinoids or their derivatives No active rheumatologic diseases (e.g., lupus) 18 years 50 years Female Development of hypersensitivity or any adverse reaction to the treatment interventions that would preclude continuation of therapy Pregnancy or plans for pregnancy within the next 6 months Active infection Active lupus or other active rheumatologic diseases Hypersensitivity to retinoids or their derivatives Immunodeficiency disorders Patient unwillingness to continue treatment E85.4 Organ-limited amyloidosis Treatment - Other Treatment - Other Treatment - Other Treatment - Drugs Intervention Group: Fractional Q-Switched Laser Group (Zone 1) Intervention Group: co2 Laser Group (Zone 2) Intervention Group: Combined Fractional Q-Switched Nd:YAG and co2 Laser Therapy (Zone 3) Control Group: Topical Kligman's Formula Therapy Hyperpigmentation improvement percentage. Timepoint: Assessments were conducted at three timepoints: (1) baseline, (2) pre-second session (3 weeks later), and (3) 4 weeks after the second intervention. Method of measurement: photography- Doctor's evaluation- Patient's self-assessment. Iran University of Medical Sciences Approved 2023-10-09 Ethics Committee of Iran University of Medical Sciences Unit 2, No. 13, Nik Roshfard St., Shadmehr St., Tehran tehran Tehran Iran (Islamic Republic of)