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IRCT20191104045328N38 IRCT 2025-07-06 Arak University of Medical Sciences Comparison of the effectiveness of intralesional tranexamic acid injection and topical fluocinolone acetonide ointment in the treatment of macular amyloidosis Comparison of efficacy of intralesional injection of tranexamic acid and topical fluocinolone acetonide ointment 0.025% in treatment of macular amyloidosis: a randomized, single-blinded, split clinical trial 2025-07-11 anticipated 21 Complete https://irct.ir/trial/84338 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method using coin flipping is employed to determine the side of the body to receive either intralesional tranexamic acid injection or fluocinolone ointment for each participant. Given that the trial design is split-body and intra-individual, each participant's body is divided into symmetrical right and left sides, and the interventions are applied independently to each side. The randomization process is carried out as follows: 1- Before the intervention begins, each participant is given a standard coin with two distinct sides (e.g., heads and tails). 2- The participant is instructed that if the coin shows heads, the right side will receive tranexamic acid and the left side will receive fluocinolone ointment. If the coin shows tails, the reverse will be applied. 3- The coin is flipped by the participant and the outcome is immediately recorded in the clinical data form. 4- Once assigned, the treatment sides remain fixed throughout the study with no crossover. 5- To ensure procedural symmetry, the dosage, application method, session timing, and outcome evaluation are performed identically and simultaneously on both sides of the body. Due to the intra-individual nature and the small sample size, coin flipping is considered a practical and appropriate method for simple randomization in this setting. No software or web-based tool will be used for this randomization. 3 Macular amyloidosis. Intervention 1: Intervention group 1: Treatment in this project is carried out using 0.025% Fluocinolone Acetonide ointment, manufactured by the Iranian company “Tehran Chemie.” The treatment involves gently rubbing the ointment onto the affected area in a quantity just enough to be absorbed by the skin without leaving any residue. This procedure is performed twice daily. Patients are advised that if they experience any symptoms indicating corticosteroid side effects (such as skin thinning, telangiectasia, etc.), they should temporarily stop using the ointment and resume treatment only after the symptoms have resolved. Intervention 2: Intervention Group 2: In the area of tranexamic acid injection, injections are administered using two units of insulin from a solution prepared with tranexamic acid at a concentration of 4 mg/mL, spaced 1 centimeter apart. The injections are performed biweekly for a total of five sessions. The tranexamic acid ampoule, manufactured by the Iranian company Aburaihan, has a concentration of 500 mg in 5 mL. Accordingly, 0.08 mL of the tranexamic acid solution is drawn using an insulin syringe and mixed with lidocaine up to the 100-unit mark on the syringe. Yes - There is a plan to make this available What will be shared: After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study. When: Access will be from 09/21/2025 to 09/21/2028 for 3 years. To whom: Academic researchers Conditions: Academic researchers, university professors, or students who wish to use the data from this study may do so after obtaining permission from the relevant individuals mentioned. They are allowed to use the data for meta-analyses or other related review studies. Additionally, upon request, the information may be used as a basis for future research or to address questions and uncertainties. Any use of this study’s data requires proper citation of the names and affiliations of the responsible individuals involved in the study. Where to obtain: Academic researchers and university professors can request access to and use of the data from Zahra Rafiei by contacting her via message or email. Contact Information: Zahra Rafiei: Phone: +98 918 482 5248 Email: Zahrar4554@gmail.com Address: Arak, Shahid Shiroudi Street, Vali Asr Hospital How to obtain: If a request for data or study documentation is submitted by researchers or relevant institutions, a formal written request must first be provided. This should include the purpose of use, the type of data requested, and the level of access required. The request will be reviewed by the principal investigator and the research ethics team. Upon approval, anonymized and de-identified data will be shared with the requester. All procedures will strictly adhere to confidentiality principles and ethical research regulations. Comments:
public Dr. Nooshin Bagherani
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 nooshinbagherani@yahoo.com Arak University of Medical Sciences scientific Dr. Mina Mirnezami
Vali Asr hospital, Shahid Shiroudi Street, Arak, Iran
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 mirnezamim@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Presence of macular amyloidosis lesions between the shoulder blades, on the arms, thighs, or above the chest, appearing relatively symmetrical on both sides. Having provided informed consent to participate in the study. 18 years 80 years Both History of any treatment aimed at removing macular amyloidosis lesions within 6 weeks prior to the start of the study Pregnancy Breastfeeding Active skin infection Systemic diseases (such as diabetes, kidney, heart, respiratory, liver diseases, or severe anemia) Bleeding disorders Connective tissue diseases Genodermatoses Smoking Alcohol consumption Drug abuse History of recurrent miscarriages No medication (including nutritional supplements) use History of allergy to tranexamic acid or fluocinolone E85 Amyloidosis Treatment - Drugs Treatment - Drugs Intervention group 1: Treatment in this project is carried out using 0.025% Fluocinolone Acetonide ointment, manufactured by the Iranian company “Tehran Chemie.” The treatment involves gently rubbing the ointment onto the affected area in a quantity just enough to be absorbed by the skin without leaving any residue. This procedure is performed twice daily. Patients are advised that if they experience any symptoms indicating corticosteroid side effects (such as skin thinning, telangiectasia, etc.), they should temporarily stop using the ointment and resume treatment only after the symptoms have resolved. Intervention Group 2: In the area of tranexamic acid injection, injections are administered using two units of insulin from a solution prepared with tranexamic acid at a concentration of 4 mg/mL, spaced 1 centimeter apart. The injections are performed biweekly for a total of five sessions. The tranexamic acid ampoule, manufactured by the Iranian company Aburaihan, has a concentration of 500 mg in 5 mL. Accordingly, 0.08 mL of the tranexamic acid solution is drawn using an insulin syringe and mixed with lidocaine up to the 100-unit mark on the syringe. Pigmentation improvement. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Pigmentation Scoring System. Pigmentation pattern. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Examination of the lesion’s waviness. Pigmentation percentage. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Pigmentation Percentage Scoring System. Skin thickness. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Examination for the presence of lesion lichenification. Itching level. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Visual Analog Scale. Patient satisfaction. Timepoint: At the beginning of the intervention, before each therapy session, and two weeks after the last therapy session. Method of measurement: Patient Satisfaction Scoring System. Arak University of Medical Sciences Approved 2025-02-23 Ethics Committee of Arak University of Medical Sciences Research Deputy, Arak University of Medical Sciences, Basij Square, Sardasht District, Arak, Iran Arak Markazi Iran (Islamic Republic of)