Comparison of tranexamic acid versus Kligman’s application in the treatment of macular amyloidosis

Comparison of efficacy and safety of intra lesional tranexamic acid injection versus topical Kligman’s formula application in the treatment of macular amyloidosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150529022468N5

Enrollment

Registered

2019-07-30

Start date

2018-11-22

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

Macular amyloidosis. Other amyloidosis

Interventions

Intervention 1: Intervention group: tranexamic acid. Six sessions of treatment every two weeks are given by the physician as an intra lesional tranexamic acid. Each session, 0.1 cc of 4 mg / ml tranex

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age range 18 to 50 years Suffering from macular amyloidosis

Exclusion criteria

Exclusion criteria: Pregnant or lactating women History of cardiovascular disease Keloid patients Patients taking anticoagulants Any allergy to the study drugs History of bleeding disorder Topical treatment three months before entering the study No consent to participate in the study

Design outcomes

Primary

Measure	Time frame
Skin darkness. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion.	—

Secondary

Measure	Time frame
Drug side effects. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: Check list.;Onset of therapeutic effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response (no amelioration) 2. poor response (amelioration less than 25%) 3. average response (amelioration from 25% to 50%) 4. good response (amelioration from 50% to 75%) 5. very good response (amelioration by more than 75%).;Continuity of drug effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response: no amelioration 2. poor response: amelioration less than 25% 3. average response: amelioration from 25% to 50% 4. good response: amelioration from 50% to 75% 5. very good response: amelioration by more than 75%.	—

Measure

Time frame

Drug side effects. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: Check list.;Onset of therapeutic effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response (no amelioration) 2. poor response (amelioration less than 25%) 3. average response (amelioration from 25% to 50%) 4. good response (amelioration from 50% to 75%) 5. very good response (amelioration by more than 75%).;Continuity of drug effect. Timepoint: 4, 8 and 12 weeks after start and 3 months after finishing the treatment. Method of measurement: The Visioface device, the third physician's opinion, and the patient's opinion. The doctor's and patient opinion will be announced through the following options: 1. No response: no amelioration 2. poor response: amelioration less than 25% 3. average response: amelioration from 25% to 50% 4. good response: amelioration from 50% to 75% 5. very good response: amelioration by more than 75%.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Ghassemi

Iran University of Medical Sciences

ghassemi.mr@iums.ac.ir+98 21 6650 2040

Outcome results

None listed

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