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Discoid Lupus ErythematosusEarly Phase 1NCT05362188

Topical Nicotinamide in Treatment of DLE

A Early Phase 1 study testing Nicotinamide Topical in people with Discoid Lupus Erythematosus, run by Al-Azhar University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Discoid Lupus Erythematosus
What is being tested?
Nicotinamide Topical
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Mar 2022to 30 Sep 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • AL-Azhar University Hospital

    Cairo, 11865

Other trials in Egypt

About this study

Official title: Efficacy and Safety of Topical Nicotinamide in Treatment of Discoid Lupus Erythematosus

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.

Being tested
Nicotinamide Topical
Medical subject headings
Lupus Erythematosus, Discoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotinamide TopicalDrug

    Also called Topical treatment of skin lesions

    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).

Study groups in NCT05362188
Study groupRoleWhat they receive
Topical Nicotinamide 2%Experimentalwill receive topical nicotinamide 2%
Receives: Drug: Nicotinamide Topical
Topical Nicotinamide 4%Experimentalwill receive topical nicotinamide 4%
Receives: Drug: Nicotinamide Topical
PlaceboPlacebo comparatorSubjects will receive only cream/gel base without API for control
Receives: Drug: Nicotinamide Topical

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severity index

    A change in discoid lupus erythematosus severity index

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

  2. Activity score

    A change in discoid lupus erythematosus activity score

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

Secondary outcomes (3)
  1. Response

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

    Measured: 2 months

  2. Remarkable response

    defined as > 50% change in activity score

    Measured: 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

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start1 Mar 2022
  3. Primary completion1 Sep 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05362188
Sponsor's protocol ID
27042022
Status last verified
Oct 2022
First submitted
26 Apr 2022
Last updated
25 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Nicotinamide Topical in people with Discoid Lupus Erythematosus, run by Al-Azhar University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity index (time frame: from base line ( visit 0 ) to 1 , 2 respectively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.

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