Topical Nicotinamide in Treatment of DLE

NCT05362188 | Completed Early Phase 1 DMC

• 1 other identifier: 27042022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cutaneous lupus erythematosus (CLE) is lupus affecting the skin. In this autoimmune disease, the body's immune system attacks healthy skin. There are 3 main types: Acute cutaneous lupus, Subacute cutaneous lupus, and Chronic cutaneous lupus ("discoid lupus"). Lupus most often appears between the ages of 20 and 50 years; it affects women more than men, and it may happen more in patients with a family history of lupus or other autoimmune diseases.

Conditions

Discoid Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Severity index

  A change in discoid lupus erythematosus severity index

  from base line ( visit 0 ) to 1 , 2 respectively

• Activity score

  A change in discoid lupus erythematosus activity score

  from base line ( visit 0 ) to 1 , 2 respectively

Secondary Outcomes (3)

• Response

  2 months

• Remarkable response

  2 months

• The dermatology life Quality Index score

  2 months

Study Arms (3)

Topical Nicotinamide 2%

EXPERIMENTAL

will receive topical nicotinamide 2%

Drug: Nicotinamide Topical

Topical Nicotinamide 4%

EXPERIMENTAL

will receive topical nicotinamide 4%

Drug: Nicotinamide Topical

Placebo

PLACEBO COMPARATOR

Subjects will receive only cream/gel base without API for control

Drug: Nicotinamide Topical

Interventions

Nicotinamide Topical DRUG

Patients with discoid lupus erythematosus (face \& scalp) will be given topical nicotinamide in two concentrations (2\&4%) to apply twice daily for 12 consecutive weeks and then follow up. Topical nicotinamide will be prepared in different forms (cream \& gel).

Also known as: Topical treatment of skin lesions

Placebo; Topical Nicotinamide 2%; Topical Nicotinamide 4%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: between 18 years and 65 years old
• Patients clinically and histopathologically newly diagnosed as DLE
• Patients clinically and histopathologically diagnosed with cutaneous lupus erythematosus that has not responded to treatment with hydroxychloroquine(200-400mg/day) plus corticosteroid at a dosage less than the equivalent of (0.5mg/kg/day) for the preceding two months or a longer period

You may not qualify if:

• Age \< 18 years old
• Pregnant and lactating women
• A history of treatments with multivitamins in the recent month
• Soft tissue infection
• Severe comorbidities including heart failure, respiratory failure
• Acute severe infections such as cellulitis or a history of HBV or HCV

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

AL-Azhar University Hospital

Cairo, 11865, Egypt

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; 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

• Ahmed Hassan Nouh, MD

  Al-Azhar university Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the principal investigator

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 5, 2022
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)