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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191104045328N38
Enrollment
21
Registered
2025-07-06
Start date
2025-07-11
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Macular amyloidosis. Amyloidosis

Interventions

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

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Nooshin Bagherani

Arak University of Medical Sciences

nooshinbagherani@yahoo.com+98 86 3222 2003

Outcome results

None listed

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