Evaluation the effect of Laser on treatment of macular amyloidosis

Phase 3

• Conditions: macular amyloidosis.; Amyloidosis of skin

• Registration Number: IRCT20140414017271N4
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 March 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

Clinically confirmed macular amyloidosis
macular amyloidosis lesions should be on upper back area
o current skin diseases like active dermatitis, active acne, hypertrophic scars or keloids
patients with Fitzpatrick skin types 2 to 4
written informed consent from patients for participation in the study and digital imaging from lesions
no use of Isotretinoin during the last 3 month
having no heart pacemaker
no record of sensitivity to lidocaine

Exclusion Criteria

unreal expectations from treatment results
macular amyloidosis lesions not being on upper back areas
intolerance against laser treatment
pregnancy during treatment
unwillingness of patient to continue participating in the study or digital imaging from lesions
Coagulopathy
Patients who were under topical treatment one month before study
existence of hypertrophic scars or keloids
Treatment with systemic retinoid during the last 6 month
other dermatologic diseases like skin infections and active lesions in the treatment area

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
esion pigmentation. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (1:low, 2:medium, 3:noticeable).;Rate of rippling. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without rippling, 1:with rippling).;Intensity of lesion. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without Lichenification, 1:with Lichenification).;Itching. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without itching, 1:with itching).