Trial Outcomes & Findings for Low-dose UVA1 Radiation in Cutaneous Lupus Patients (NCT NCT01776190)

Last Updated: 2023-08-25

Results Overview

The CLASI activity score represents the amount of skin disease activity in cutaneous lupus patients, as evaluated by a provider. The minimum score is 0 (no disease activity), and the maximum score is 70 (maximum/worst disease activity). The change is measured at the start and end of the UVA1 trial therapy.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

10 weeks

Results posted on

2023-08-25

Participant Flow

Participant milestones

Participant milestones
Measure	UVA1 Treatment Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-dose UVA1 Radiation in Cutaneous Lupus Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UVA1 Treatment n=6 Participants Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	37.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: Cutaneous Lupus Erythematosus patients

Outcome measures

Outcome measures
Measure	UVA1 Treatment n=5 Participants Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score	-1 Units on a scale Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: 10 weeks

The CLASI damge score represents the amount of skin disease damage in cutaneous lupus patients, as evaluated by a provider. The minimum score is 0 (no disease damage), and the maximum score is 80 (maximum/worst disease damage). The change is measured at the start and end of the UVA1 trial therapy.

Outcome measures

Outcome measures
Measure	UVA1 Treatment n=5 Participants Low-dose UVA1 will be applied to active cutaneous lupus lesions three times a week for 10 weeks. UVA1 radiation treatment
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score	0 Units on a scale Interval 0.0 to 2.0

Adverse Events

UVA1 Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Benjamin Chong, MD

University of Texas Southwestern Medical Center

Phone: 214-645-2400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place