NCT03178188

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2017

Completed
Last Updated

June 6, 2017

Status Verified

June 1, 2017

Enrollment Period

12 months

First QC Date

June 2, 2017

Last Update Submit

June 5, 2017

Conditions

Lupus Erythematosus, Discoid

Keywords

lupus erythematosus, DiscoidPulsed-dye Laser

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • modified Cutaneous Lupus Erythematosus Disease Area and Severity Index(mCLASI)

    week 0, 4, 8, 12, 16, 24

  • Physician Global Assessment (PGA) scores

    week 0, 4, 8, 12, 16, 24

  • texture index (TI)

    week 0, 4, 8, 12, 16, 24

Study Arms (2)

laser treated DLE lesions

EXPERIMENTAL

DLE which received the pulsed-dye laser

Device: Pulsed-dye Laser

sham treated DLE lesions

SHAM COMPARATOR

DLE which received the sham

Device: Sham

Interventions

Pulsed-dye LaserDEVICE

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

laser treated DLE lesions
ShamDEVICE

Cryogen spray with the setting of dynamic cooling device 30/20

sham treated DLE lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or lactation
  • History of skin cancer
  • History of photo allergy
  • History of bleeding tendency
  • History of abnormal wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Dermatology, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

Lasers, Dye

Condition Hierarchy (Ancestors)

Lupus Erythematosus, CutaneousConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Central Study Contacts

Pawinee Rerknimitr, MD

CONTACT

pawineererk@yahoo.co.th

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 6, 2017

Study Start

December 15, 2016

Primary Completion

December 14, 2017

Study Completion

December 14, 2017

Last Updated

June 6, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)