Status:
UNKNOWN
Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus
Lead Sponsor:
Second Xiangya Hospital of Central South University
Collaborating Sponsors:
National Natural Science Foundation of China
Hunan Provincial Natural Science Foundation of China
Conditions:
Cutaneous Lupus Erythematosus
Systemic Lupus Erythematosus Rash
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This clinical study will test the efficacy and safety of nicotinamide for lupus-associated skin lesions refractory to the treatment of hydroxychloroquine plus low-dose corticosteroids in patients with...
Detailed Description
Backgrounds: Lupus erythematosus (LE) is an autoimmune disease affecting various organs. Lupus-associated skin lesions are the dominant clinical manifestations of cutaneous lupus erythematosus (CLE) a...
Eligibility Criteria
Inclusion
- Age: between 18 years and 65 years.
- 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.
- 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.
- 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.
- Written informed consent form.
Exclusion
- 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.
- 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).
- A history of treatment with nicotinamide, niacin, or multi-vitamins in the recent month.
- 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.
- 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.
- Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment.
- Pregnancy or lac¬tation in females.
- Participants in other clinical trials.
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03260166
Start Date
August 31 2017
End Date
July 1 2021
Last Update
February 2 2021
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011