18 and older, any sex, with Cutaneous Lupus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Limited CLASIPrimary· 2 Months
The investigators are using a limited Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scoring system to classify specific lesions the investigators are measuring. The total limited CLASI reflects the sum of both active and damage CLASI, resulting in a score ranging from 0 to 8. A higher score indicates more severe disease. Score is assessed by the investigators.
The limited active CLASI for a lesion will include the following:
* Erythema (ranging from 0 = absent to 3 = dark red/purple)
* Scale/Hypertrophy (ranging from 0 = absent to 2 = verrucous/ hypertrophic)
* The ad
Baseline
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
5
5 – 5
1064nm Laser and Topical Corticosteroid
4
2 – 5
Topical Corticosteroid Alone
4.3
3 – 6
1 Month
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
5
5 – 5
1064nm Laser and Topical Corticosteroid
3.66
2 – 5
Topical Corticosteroid Alone
4
3 – 5
2 Months
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
5
5 – 5
1064nm Laser and Topical Corticosteroid
3.66
2 – 6
Topical Corticosteroid Alone
4.33
3 – 6
VAS for AppearancePrimary· 2 Months
The investigators are using a VAS (visual analog scale) to measure patient assessment of the appearance of the lesion. The scale ranges from 0-10, with 10 being very satisfied and 0 being no satisfaction at all.
A score of 0 will represent a cosmetically fully unsatisfactory result and 10 will represent cosmetically excellent result.
Baseline
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
7.5
7.5 – 7.5
1064nm Laser and Topical Corticosteroid
3.2
1.4 – 6.3
Topical Corticosteroid Alone
4.2
1.8 – 5.5
1 Month
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
10
10 – 10
1064nm Laser and Topical Corticosteroid
7.5
6.4 – 9
Topical Corticosteroid Alone
5.5
3.5 – 8
2 Months
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
9
9 – 9
1064nm Laser and Topical Corticosteroid
6.5
4 – 7.8
Topical Corticosteroid Alone
3.6
2 – 5.5
VAS for PainPrimary· 1 Month
The investigators are using a VAS (visual analog scale) to assess pain of the laser treatment. The participant rates the pain of the laser treatment. The scale ranges from 0 (no pain) to 10(worse pain).
A score of 0 will represent absence of pain and 10 will represent maximal pain.
Baseline
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
1.4
1.4 – 1.4
1064nm Laser and Topical Corticosteroid
3.1
0 – 5
1 Month
Group
Value
95% CI
532nm Laser and Topical Corticosteroid
6
6 – 6
1064nm Laser and Topical Corticosteroid
2.13
1 – 3.1
Sponsor's own description
This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by David Weinstein
Last refreshed: 21 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03639857.