Nicotinamide Treatment for Lupus-associated Skin Lesions in Lupus Erythematosus

NCT03260166 | Unknown Phase 2

• 1 other identifier: PFK201707
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE).

Conditions

Cutaneous Lupus Erythematosus; Systemic Lupus Erythematosus Rash

Keywords

nicotinamide; lupus-associated skin lesion; lupus erythematosus

Outcome Measures

Primary Outcomes (1)

• A change in Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI) activity score

  The higher the RCLASI score, the worse of the lupus-associated skin lesion is.

  from baseline (at visit 0) to 3 months treatment (at visit 3)

Secondary Outcomes (14)

• A change in RCLASI activity score

  from baseline (at visit 0) to 1, 2, 4, and 6 months treatment (at visit 1, 2, 4, and 5), respectively

• Response Rate and Remarkable Response Rate at 1, 2, 3, 4, and 6 months, respectively

  1 month, 2 months, 3 months, 4 months, and 6 months

• Number of Relapses

  4 months, 6 months

• A change in Dermatology Life Quality Index (DLQI) score

  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 Physician's Global Assessment (PGA) score

  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

Study Arms (1)

nicotinamide

EXPERIMENTAL

Patients will receive 10 nicotinamide tablets orally twice daily (nicotinamide 500 mg, p.o., Bid) for a period of 3 months. Each tablet contains 50 mg of nicotinamide.

Drug: nicotinamide

Interventions

nicotinamide DRUG

Drug: nicotinamide; Pharmaceutical form: tablet; Route of administration: oral

Also known as: Niacinamide

nicotinamide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead
• National Natural Science Foundation of China: collaborator
• Hunan Provincial Natural Science Foundation of China: collaborator
• National Key Clinical Specialty Construction Project of China: collaborator

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Qianjin Lu, MD, PhD

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Dept. of Dermatology, The Second Xiangya Hospital of Central South University

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 24, 2017
• Study Start: August 31, 2017
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2021
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)