Efficacy of 595 nm Pulsed-dye Laser in Treatment of Discoid Lupus Erythematosus

Lupus Erythematosus, Discoid Clinical Trial

Official title:

Efficacy of 595 nm Pulsed-dye Laser as an Adjunctive Treatment of Discoid Lupus Erythematosus, A Randomized, Patient/Assessor Blinded Placebo Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178188
• Other study ID #: 1/59
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 2, 2017
• Last updated: June 5, 2017
• Start date: December 15, 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: June 2017
• Source: Chulalongkorn University
• Contact: Pawinee Rerknimitr, MD
• Email: pawineererk[@]yahoo.co.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

forty DLE lesions from patients will be recruited in the study. The lesions on one side of the body were block-randomized into the treatment group and the other side served as a control. The patients can continue their systemic treatments and the PDL is designed to be used as an adjunctive treatment. Treatments with the PDL will be delivered in the treatment group every 4 weeks for 4 consecutive months while the lesions in the control group received a sham. The patients will be evaluated at baseline (week 0), week 4, 8, 12, and at follow-up period of 4, 12 weeks after the final treatment (week 16, 24). Erythema index (EI), Texture index (TI) will be obtained and digital photographs will be taken and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) will be assessed in every visit. The digital photographs will later be evaluated by 3-blinded dermatologists. Moreover, side effects and patients' satisfaction score will also be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Has at least two DLE lesions, located in the same anatomical location of the body, which the different of mCLASI are not more than 1 point

• Dose not undergo any procedure or laser treatment within 4 weeks before entered the study

• Dose not received any localised therapy of DLE eg. topical corticosteriod/immunomodulator within 4 weeks before entered the study

• Dose not receive the topical chemical peeling within 4 weeks before entered the study

• Has already received at least 1 systemic standard treatment for DLE and continue until the rest of the study

• Can follow the study's protocol

Exclusion Criteria:

• Pregnancy or lactation

• History of skin cancer

• History of photo allergy

• History of bleeding tendency

• History of abnormal wound healing

Related Conditions & MeSH terms

• Lupus Erythematosus, Discoid
• Lupus Erythematosus, Systemic

Intervention

Device:
• Pulsed-dye Laser
595 nm Pulsed-dye Laser; 7mm spot sizes, 6msec pulse durations, 8j/cm2 fluences, dynamic cooling device 30/20, 4 sessions with 4 weeks interval
• Sham
Cryogen spray with the setting of dynamic cooling device 30/20

Locations

Country	Name	City	State
Thailand	Division of Dermatology, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	erythema index (EI)	Comparing changes of EI from baseline between treated group and controlled group, measured by Antera 3D camera	week 0(baseline), 4, 8, 12, 16, 24
Secondary	modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)	Comparing changes of mCLASI from baseline between treated group and controlled group, measured by 1-blinded dermatologist	week 0, 4, 8, 12, 16, 24
Secondary	Physician Global Assessment (PGA) scores	Comparing overall improvement changes from baseline (PGA scores) measured by 3-blinded dermatologist	week 0, 4, 8, 12, 16, 24
Secondary	texture index (TI)	Comparing changes of TI from baseline between treated group and controlled group, measured by Antera 3D camera	week 0, 4, 8, 12, 16, 24