Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis

Phase 3

Recruiting

• Conditions: Macular Amyloidosis.; Other amyloidosis; e85.8

• Registration Number: IRCT20220101053588N1
• Lead Sponsor: Skin Research Center Of Shahid Beheshti Universiy Of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Age 18-60
Confirming the diagnosis of macular amyloidosis by a dermatologist
bilateral macular amyloidosis on trunk and extremities
Patients with skin type 2_4 Fitzpatrick
Filling out the informed consent form

Exclusion Criteria

Pregnancy and lactation
Past history of keloid formation
Presence of active acne on site of macular amyloidosis
Other skin disorders
Hypersensitivity to lidocaine
Application of other topical medications in the past month

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical improvement of pigmentation. Timepoint: first session and two weeks after final session. Method of measurement: comparison of photos by 2 dermatologist and fotofinder device.;Pigmentation pattern. Timepoint: first session and two weeks after final session. Method of measurement: checking for rippling.;Patient satisfaction. Timepoint: two weeks after final session. Method of measurement: asking the patient.

Secondary Outcome Measures

Name	Time	Method
Side effects. Timepoint: Since 2weeks after starting of the treatment, till 2 weeks after the last session. Method of measurement: Asking the patient, examination by dermatologist.