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.
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.
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.
- Conditions
- Discoid Lupus Erythematosus
- 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 group | Role | What they receive |
|---|---|---|
| Topical Nicotinamide 2% | Experimental | will receive topical nicotinamide 2% Receives: Drug: Nicotinamide Topical |
| Topical Nicotinamide 4% | Experimental | will receive topical nicotinamide 4% Receives: Drug: Nicotinamide Topical |
| Placebo | Placebo comparator | Subjects 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.
Severity index
A change in discoid lupus erythematosus severity index
Measured: from base line ( visit 0 ) to 1 , 2 respectively
Activity score
A change in discoid lupus erythematosus activity score
Measured: from base line ( visit 0 ) to 1 , 2 respectively
Secondary outcomes (3)
Response
defined as > 25% change in activity score at the end of treatment
Measured: 2 months
Remarkable response
defined as > 50% change in activity score
Measured: 2 months
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.
- First posted5 May 2022
- Study start1 Mar 2022
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hassan Nouh MD, Al-Azhar University
- Investigators
- Ahmed Hassan Nouh, MD, Principal investigator, Al-Azhar university Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Nicotinamide in Treatment of Discoid Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05362188
- Acronym / sponsor ID
- 27042022
- Conditions
- Discoid Lupus Erythematosus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical Nicotinamide 2% | Experimental | Drug: Nicotinamide Topicalwill receive topical nicotinamide 2% |
| Topical Nicotinamide 4% | Experimental | Drug: Nicotinamide Topicalwill receive topical nicotinamide 4% |
| Placebo | Placebo comparator | Drug: Nicotinamide TopicalSubjects will receive only cream/gel base without API for control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide TopicalAlso: Topical treatment of skin lesionsPatients 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). | Drug | Placebo, Topical Nicotinamide 2%, Topical Nicotinamide 4% |
Primary outcome
Severity index
Time frame: from base line ( visit 0 ) to 1 , 2 respectively
A change in discoid lupus erythematosus severity index
Activity score
Time frame: from base line ( visit 0 ) to 1 , 2 respectively
A change in discoid lupus erythematosus activity score
3 secondary outcomes
Response
Time frame: 2 months
Remarkable response
Time frame: 2 months
The dermatology life Quality Index score
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Discoid Lupus Erythematosus
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
RecruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Active, not recruitingPhase 2/3
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Hassan Nouh, MD principal investigator
Al-Azhar university Hospital
1 site in 1 country: see every site and its status.
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.