Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03260166
• Date of registration: 10/08/2017
• Prospective Registration: Yes
• Primary sponsor: Second Xiangya Hospital of Central South University
• Public title: Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus
• Scientific title: An Open-label Study for Assessing the Efficacy and Safety of Nicotinamide Treatment for Lupus-associated Skin Lesions in Patients With Cutaneous Lupus Erythematosus or Systemic Lupus Erythematosus
• Date of first enrolment: August 31, 2017
• Target sample size: 40
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03260166
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Qianjin Lu, MD, PhD
• Affiliation: Central South University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age: between 18 years and 65 years.

2. Patients clinically and histopathologically diagnosed as cutaneous lupus erythematosus
(CLE) that have not respond to treatment with hydroxychloroquine (200-400 mg/day) plus
corticosteroids at a dosage less than the equivalent of 0.5mg/kg/day of prednisone for
the preceding two months or a longer period.

3. Patients diagnosed as SLE (meeting the 1997 American College of Rheumatology criteria
for SLE) that present with lupus-associated skin lesions that have not respond to
treatment with hydroxychloroquine (200-400 mg/day) plus corticosteroids at a dosage
less than the equivalent of 0.5mg/kg/day of prednisone for the preceding two months or
a longer period.

4. Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) =4; for
patients with SLE, Safety of Estrogens in Lupus Erythematosus National Assessment
version of the systemic lupus erythematosus disease activity index (SELENA-SLEDAI) is
within the range between 0 and 9.

5. Written informed consent form.

Exclusion Criteria:

1. Severe comorbidities including heart failure (=grade III NYHA), respiratory failure,
renal insufficiency (creatinine clearance =30 ml/min), hepatic insuf¬ficiency (alanine
aminotransferase or aspartate aminotransferase =2 times of the upper limit of the
normal range), or active severe neuropsychiatric manifestations of SLE.

2. Acute severe infection such as sepsis and cellulitis, or a history of infection of
hepatitis B or C virus, Mycobacterium tuberculosis, or human immunodeficiency virus
(HIV).

3. A history of treatment with nicotinamide, niacin, or multi-vitamins in the recent
month.

4. A history of treatment with rituximab or other biologics; or a history of treatment
with high-dose corticosteroids (=1.5 mg/kg/d), immunosuppressants, tripterygium
glycosides, or intravenous immunoglobin G (IVIG) in the preceding three months.

5. Patients not suitable for using nicotinamide due to comorbidities including pruritic
skin diseases such as atopic dermatitis and urticaria, vertigo, dizziness, headache,
hyperglycemia, and hyperuricemia; patients not suitable for using hydroxychloroquine
due to conditions including retinopathy or hypersensitivity to hydroxychloroquine.

6. Patients with drug abuse, alcohol abuse, or mental disorders that are unable to
cooperate or adhere to treatment.

7. Pregnancy or lac¬tation in females.

8. Participants in other clinical trials.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus Rash

Cutaneous Lupus Erythematosus

Intervention(s)

Drug: nicotinamide

Primary Outcome(s)

A change in Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) activity score [Time Frame: from baseline (at visit 0) to 3 months treatment (at visit 3)]

Secondary Outcome(s)

A change in RCLASI activity score [Time Frame: from baseline (at visit 0) to 1, 2, 4, and 6 months treatment (at visit 1, 2, 4, and 5), respectively]

A change in serum levels of complement 3 (C3), C4, and C1q [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

A change in the results of urine sediment test [Time Frame: 1 month, 2 months, 3 months, 4 months, and 6 months]

A change in Physician's Global Assessment (PGA) score [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

A change in the percentage of different T helper cell (Th) subsets among CD4+ T lymphocytes [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

A change in the serum level of cytokines interferon (IFN)?, interleukin (IL)-4, IL-17A, transforming growth factor (TGF)-ß, IL-10, IL-21, and IL-6 [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

Incidence of side effects [Time Frame: 6 months]

A change in Dermatology Life Quality Index (DLQI) score [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

Dose reduction of concomitant corticosteroids [Time Frame: from baseline (at visit 0) to 3 months, 4 months, and 6 months (at visit 3, 4, and 5), respectively]

A change in British Isles Lupus Assessment Group 2004 Index (BILAG-2004) [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

A change in SELENA-SLEDAI (Safety of Estrogens in Lupus Erythematosus National Assessment version of the systemic lupus erythematosus disease activity index) [Time Frame: from baseline (at visit 0) to 1 month, 2 months, 3 months, 4 months, and 6 months (at visit 1, 2, 3, 4, and 5), respectively]

Response Rate and Remarkable Response Rate at 1, 2, 3, 4, and 6 months, respectively [Time Frame: 1 month, 2 months, 3 months, 4 months, and 6 months]

Incidence of side effects [Time Frame: 3 months]

Number of Relapses [Time Frame: 4 months, 6 months]

Secondary ID(s)

PFK201707

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Key Clinical Specialty Construction Project of China

Hunan Provincial Natural Science Foundation of China

National Natural Science Foundation of China