- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362188
Topical Nicotinamide in Treatment of DLE
Efficacy and Safety of Topical Nicotinamide in Treatment of Discoid Lupus Erythematosus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
DLE is the most common form of chronic cutaneous erythematosus and can occur as a localized form (80%) with lesions on the face, ears, and scalp or as disseminated DLE (20%) with lesions above and below the neck. The disseminated form of DLE, especially when involving the trunk, is associated with an increased risk of progression to SLE. It is unusual for discoid lesions to be present below the neck without lesions also being present above the neck. Occasionally, discoid lesions develop on mucosal surfaces, including the lips, nasal mucosa, conjunctivae, and genital mucosa. Some patients with discoid lesions exhibit a photodistribution. Sun exposure seems to play a role in the development of lesions.
For discoid lupus erythematosus without associated SLE (CDLE), the evidence does not show whether circulating inflammatory cells and autoantibodies are involved in the pathogenesis, but it is evident that the cutaneous inflammatory infiltrates are dominated by Th1.
The first morphological sign of DLE is a well-defined, annular erythematous patch or plaque of varying size followed by follicular hyperkeratosis, which is adherent to the skin. By removing the adherent scale, follicle-sized keratotic spikes similar to carpet tacks can be seen ("carpet tack sign"). The lesions slowly expand with active inflammation and hyperpigmentation at the periphery leaving depressed central atrophy and scarring, telangiectasia, and hypopigmentation. DLE can progress to irreversible scarring alopecia on the scalp. Although uncommon, a squamous cell carcinoma can develop in a longstanding discoid lesion.
A biopsy from the lesion for routine histologic examination is usually diagnostic of DLE. Atrophic epidermis, keratotic plugging of the follicles, hydropic degeneration of the basal cells, and patchy perivascular and perifollicular lymphocytic infiltrate are characteristic.
Early treatment of discoid lupus lesions may lead to the total clearing of skin lesions, but treatment failure results in permanent scarring. Hair loss, depressed scars, and pigmentary changes are often disfiguring, particularly in darker-skinned people. Some general measures, such as sun avoidance and liberal application of sunscreen, are encouraged because cutaneous lesions are known to be exacerbated by sunlight. Smoking cessation is encouraged, as this can increase DLE disease activity.
While antimalarials such as hydroxychloroquine have been widely used as a first-line treatment for lupus-associated skin lesions, 30% of patients with lupus do not respond to this medication. Other available therapies such as corticosteroids and thalidomide can also be applied, however, their toxic side effects limit their clinical use. Recent studies by the investigators have shown that nicotinamide, a water-soluble vitamin whose side effects are considered minimal, can protect against skin lesions and autoantibody production. Thus it is hypothesized that nicotinamide treatment could be a novel therapy for lupus-associated skin lesions in patients with LE.
Nicotinamide is the amide form of vitamin B3 . It is the precursor of numerous reactions in the body including adenosine triphosphate (ATP) production and consequently can be used in many dermatological disorders.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt, 11865
- Al-Azhar University hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Topical Nicotinamide 2%
will receive topical nicotinamide 2%
|
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).
Other Names:
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Experimental: Topical Nicotinamide 4%
will receive topical nicotinamide 4%
|
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).
Other Names:
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Placebo Comparator: Placebo
Subjects will receive only cream/gel base without API for control
|
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).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity index
Time Frame: from base line ( visit 0 ) to 1 , 2 respectively
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A change in discoid lupus erythematosus severity index
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from base line ( visit 0 ) to 1 , 2 respectively
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Activity score
Time Frame: from base line ( visit 0 ) to 1 , 2 respectively
|
A change in discoid lupus erythematosus activity score
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from base line ( visit 0 ) to 1 , 2 respectively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response
Time Frame: 2 months
|
defined as > 25% change in activity score at the end of treatment
|
2 months
|
Remarkable response
Time Frame: 2 months
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defined as > 50% change in activity score
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2 months
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The dermatology life Quality Index score
Time Frame: 2 months
|
A change in Dermatology life Quality Index score as it reflects the quality of life related to skin manifestations
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmed Hassan Nouh, MD, Al-Azhar University hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Connective Tissue Diseases
- Lupus Erythematosus, Cutaneous
- Lupus Erythematosus, Discoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Niacinamide
- Niacin
Other Study ID Numbers
- 27042022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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