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CompletedNCT05362188Updated Oct 25, 2022

Topical Nicotinamide in Treatment of DLE

An Early Phase 1 interventional study of Nicotinamide Topical in Discoid Lupus Erythematosus, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Al-Azhar University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Discoid Lupus Erythematosus
03

In context

Lupus Erythematosus, Discoid

40 studies on the registry are indexed under Lupus Erythematosus, Discoid; 6 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 31 interventional studies indexed under Lupus Erythematosus, Discoid.

Browse Lupus Erythematosus, Discoid studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Topical Nicotinamide 2%

    will receive topical nicotinamide 2%

    Drug: Nicotinamide Topical

  • Experimental
    Topical Nicotinamide 4%

    will receive topical nicotinamide 4%

    Drug: Nicotinamide Topical

  • Placebo comparator
    Placebo

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

    Drug: Nicotinamide Topical

Interventions

  • DrugNicotinamide Topical

    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

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What researchers measure

Primary outcomes

  1. Severity index

    A change in discoid lupus erythematosus severity index

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

  2. Activity score

    A change in discoid lupus erythematosus activity score

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

Secondary outcomes

  1. Response

    defined as \> 25% change in activity score at the end of treatment

    Time frame: 2 months

  2. Remarkable response

    defined as \> 50% change in activity score

    Time frame: 2 months

  3. The dermatology life Quality Index score

    A change in Dermatology life Quality Index score as it reflects the quality of life related to skin manifestations

    Time frame: 2 months

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Study locations

1 site
  • AL-Azhar University Hospital
    Cairo, 11865, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05362188
Lead sponsor
Al-Azhar University
Responsible party
Ahmed Hassan Nouh MD (the principal investigator, Al-Azhar University) — Principal investigator
First posted
May 5, 2022
Start date
Mar 1, 2022
Primary completion
Sep 1, 2022
Completion
Sep 30, 2022
Last update
Oct 25, 2022

Study contacts

Ahmed Hassan Nouh, MD
principal investigator · Al-Azhar university Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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