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Comparison of tranexamic acid and platelet-rich plasma for the treatment of macular amyloidosis

Comparison of the efficacy and safety of intralesional injection of tranexamic acid and Platelet Rich Plasma in the treatment of macular amyloidosis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250630066301N3
Enrollment
18
Registered
2025-09-29
Start date
2025-09-11
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Amyloidosis. Amyloidosis of skin, Lichen amyloidosis, Macular amyloid

Interventions

Intervention 1: In this side, intralesional injection of tranexamic acid (Tranexamic acid, concentration: 500 mg in 5 mL
brand name: Tranexip, manufactured by Caspian Pharmaceutical Company) is administered. The injection is performed intradermally using a 1 mL insulin syringe and, at an approximate depth of 1 cm. A vol

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients must be 18 years of age or older. Patients must have a diagnosis of cutaneous amyloidosis via clinical manifestations. Patients must be willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Patients have a history of sensitivity to TXA or PRP components. Patients are currently using anticoagulants or antiplatelet therapy. Patients have an active infection at the injection site. Patients are pregnant or breastfeeding. Patients have a history of treatment with anti-pigmentation drugs in the past 3 months. Patients have a history of recent bleeding for any reason. Patients are undergoing hormone therapy or concomitant use of contraceptives. Patients have used topical treatments containing corticosteroids, peels, or lighteners in the study areas within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Patient scoring of changes in color and itching of skin lesions. Timepoint: Treatment response is assessed at 4, 8, and 12 weeks after initiation, as well as 3 months after the end of treatment, and compared to baseline (day zero). Method of measurement: The researcher-designed questionnaire included a 5-point ordinal scale to assess the degree of improvement, satisfaction with the appearance of the lesions, and reduction of symptoms such as itching and pain from the patient's perspective; scoring was done as follows: 0 = no improvement, 1 = slight improvement (75%).;Scoring of changes in skin lesion color by two dermatologists. Timepoint: Treatment response is assessed at 4, 8, and 12 weeks after initiation, as well as 3 months after the end of treatment, and compared to baseline (day zero). Method of measurement: Patients are examined by two dermatologists and the degree of improvement of their lesions is scored: 0 no improvement, 1 slight improvement (75%).;Scoring of changes in dermoscopic criteria and evaluation of patterns in macular amyloidosis. Timepoint: Treatment response is assessed at 4, 8, and 12 weeks after initiation, as well as 3 months after the end of treatment, and compared to baseline (day zero). Method of measurement: Dermoscopic criteria will be evaluated by two board-certified dermatologists during physical examinations using a dermoscope. The evaluation will be based on predefined dermoscopic parameters such as pigmentation pattern, presence of rippling, central hub, and perifollicular changes. Assessments will be performed before and after the intervention. Each criterion will be scored as improved, unchanged, or worsened. In case of disagreement between the two dermatologists, consensus will be reached or the mean score will be used.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKiana Rahmati

Mashhad University of Medical Sciences

Kianarahmati222@gmail.com+98 51 3800 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026