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

Comparison of efficacy of intralesional injection of tranexamic acid and topical fluocinolone acetonide ointment 0.025% in treatment of macular amyloidosis

The present study is an open-label, parallel-group, randomized (using coin toss) clinical trial involving 21 patients.

This open-label randomized clinical trial included 21 macular amyloidosis patients from Valiasr Hospital in Arak. Participants were randomly assigned (via coin toss) to one of two treatment arms(Tranexamic acid therapy, Fluocinolone acetonide therapy). ّFinal outcomes were then compared between the two treatment groups.

Inclusion criteria: Presence of relatively symmetrical macular amyloidosis lesions in specified areas; informed consent for study participation. Exclusion criteria: History of any treatment for the removal of macular amyloidosis within 6 weeks before the start of the study; Pregnancy and lactation; ; active infections; significant systemic diseases; smoking, alcohol consumption, or drug abuse; history of multiple miscarriages; History of allergy to tranexamic acid or fluocinolone.

Intervention group (Tranexamic Acid): Participants receive intralesional injections of tranexamic acid at a concentration of 4 mg/mL, administered every two weeks for a total of five sessions. The solution is combined with lidocaine prior to injection. Control group (Fluocinolone): Participants apply 0.025% fluocinolone acetonide ointment topically twice daily. In case of corticosteroid-related side effects, treatment is temporarily discontinued and resumed once symptoms resolve.

Pigmentation improvement , pigmentation pattern, pigmentation percentage, skin thickness, itching level, patient satisfaction.

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.

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.

Access will be from 09/21/2025 to 09/21/2028 for 3 years.

Academic researchers

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.

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

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.