LeprosyNCT06819449
Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients
A study testing Dapsone in people with Leprosy and Mycobacterium Leprae Infection, run by South Valley University at 1 site in Egypt.
Trial summary
Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Leprosy, Mycobacterium Leprae Infection
- What is being tested?
- Dapsone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both sexes with positive slit skin smear for m.leprae .
Who cannot join
- Contraindications to Multi drug therapy :
- Patients with hypersensitivity to sulfa .
- Patients with hypersensitivity to clofazimine or rifampcin.
- pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Qina University hospital, South Valley University Hospital
Qina
Mohammed Hosny Hassan, Professor, +201098473605, mohammedhosnyhassaan@med.svu.edu.eg
Soheir Abdel-hamid Ali, M.D, +201066877343, Soher.abdel-hamid@med.svu.edu.eg
About this study
Official title: Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multiple Drug Therapy: Randomized Clinical Trial
Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. The bacteria is subsequently transported by the bloodstream to the peripheral nerves, where it can result in tissue damage from painless burns and ulcers as well as irreparable nerve damage that results in a loss of protective feeling.
Read the detailed description
One of the most common host cells that mycobacteria encounter is macrophages. The process of monocyte-derived macrophages phagocytosing M. leprae is controlled by protein kinase and can be facilitated by complement receptors CR1 (CD35), CR3 (CD11b/CD18), and CR4 (CD11c/CD18). A Th2 cytokine profile appears to be correlated with nonreactivity to M.Leprea.
The Ridley-Jopling classification (1962) divides leprosy into six forms: Tuberculoid (TT), Borderline Tuberculoid (BT), Borderline-borderline Mid-borderline (BB), Borderline-Lepromatous (BL), Subpolar Lepromatous (LLs), and Polar Lepromatous (LLp). These categories are based on clinical, histopathological, and immunological criteria. According to WHO, leprosy is classified into two groups: the paucibacillary (PB) and multibacillary (MB) types, to aid in treatment.
Leprosy is treated as an outpatient procedure using WHO-standardized regimens from 1982, which essentially consist of three first-line medications: clofazimine, rifampicin, and dapsone. This relationship is referred to as polychemotherapy, or MDT (PCT). With minimal bactericidal activity, sulfone (diaminodiphenyl sulfone, or DDS), commonly referred to as dapsone, primarily acts as a bacteriostatic agent.
It most likely functions as an antagonist of para- aminobenzoic acid (PABA), preventing M. leprae from using it to synthesize folic acid. It is well-tolerated and has a number of adverse effects, most of which do not require stopping treatment.
The primary bactericidal effect of rifampicin (RMP), a semi-synthetic derivative of rifamycin B, is observed. It functions by preventing the RNA-polymerase enzyme in the bacillus from growing. RMP has been used to treat leprosy since 1963. Most of the bacilli become non-viable after a few days of therapy, and its use is crucial in all clinical types of leprosy. Clofazimine (CLF) is an iminophenazine dye . It has a mild bactericidal action, acting slowly on M. leprae and destroying 99% of the bacteria in approximately five months. Its efficacy is similar to DDS. CLF has an important anti-inflammatory action.
With an estimated heritability of up to 57%, family studies and community epidemiological surveys have amply established the significant role that host genetics plays in an individual's vulnerability to leprosy.
RAB32 is a low molecular weight G protein belonging to the Ras superfamily. It is necessary for the production of autophagic vacuoles and the control of autophagy's removal of aggregated proteins. Rab32 may play a similar role in the pathogenesis of leprosy, according to a recent study that found the protein controls the recruitment of cathepsin D to phagosomes containing Mycobacterium tuberculosis.
- Conditions
- Leprosy, Mycobacterium Leprae Infection
- Being tested
- Dapsone
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapsoneDrug
Also called clofazimine, rifampcin
To evaluate the effect of the multi drug therapy in leprotic patients and their side effects and to assess the role of Rab 32 gene in leprosy prognosis and to know its association with the multi drug therapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Leprosy Patients | Active comparator | About 40 patients suffering from Leprosy and will treated by Multi drug therapy as ( dapsone _ clofazimine _ rifampcin) then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant At the end of third month therapy. Receives: Drug: Dapsone |
| Group B: Healthy People | Active comparator | About 10 Healthy People. no drugs used and then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant Receives: Drug: Dapsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of leprosy
About 40 of Participants With Treatment-Related Adverse Events as Assessed by measuring the of Rab 32 gene ( Rs2275606 ) polymorphism using real time PCR for Evaluation of the multi drug therapy on Leprotic Patients
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Dec 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Atef Nassief, South Valley University
- Investigators
- Eisa Mohammed Hegazy, Assist. Prof, Study chair, Dermatology, Venereology and Andrology. Faculty of Medicine,South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819449
- Sponsor's protocol ID
- Rab 32 gene polymorphisms
- Status last verified
- Dec 2024
- First submitted
- 21 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multiple Drug Therapy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06819449
- Acronym / sponsor ID
- Rab 32 gene polymorphisms
- Conditions
- Leprosy, Mycobacterium Leprae Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 11 Feb 2025 (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.
Mycobacterium leprae is a slow-growing bacillus that causes leprosy. the infection may take two to ten years to incubate. While the exact mechanism of infection transmission is unknown, direct bacillus absorption through the nasal or respiratory mucosa and aerosolized nasal secretions are the most common theories. The bacteria is subsequently transported by the bloodstream to the peripheral nerves, where it can result in tissue damage from painless burns and ulcers as well as irreparable nerve damage that results in a loss of protective feeling.
Detailed description
One of the most common host cells that mycobacteria encounter is macrophages. The process of monocyte-derived macrophages phagocytosing M. leprae is controlled by protein kinase and can be facilitated by complement receptors CR1 (CD35), CR3 (CD11b/CD18), and CR4 (CD11c/CD18). A Th2 cytokine profile appears to be correlated with nonreactivity to M.Leprea.
The Ridley-Jopling classification (1962) divides leprosy into six forms: Tuberculoid (TT), Borderline Tuberculoid (BT), Borderline-borderline Mid-borderline (BB), Borderline-Lepromatous (BL), Subpolar Lepromatous (LLs), and Polar Lepromatous (LLp). These categories are based on clinical, histopathological, and immunological criteria. According to WHO, leprosy is classified into two groups: the paucibacillary (PB) and multibacillary (MB) types, to aid in treatment.
Leprosy is treated as an outpatient procedure using WHO-standardized regimens from 1982, which essentially consist of three first-line medications: clofazimine, rifampicin, and dapsone. This relationship is referred to as polychemotherapy, or MDT (PCT). With minimal bactericidal activity, sulfone (diaminodiphenyl sulfone, or DDS), commonly referred to as dapsone, primarily acts as a bacteriostatic agent.
It most likely functions as an antagonist of para- aminobenzoic acid (PABA), preventing M. leprae from using it to synthesize folic acid. It is well-tolerated and has a number of adverse effects, most of which do not require stopping treatment.
The primary bactericidal effect of rifampicin (RMP), a semi-synthetic derivative of rifamycin B, is observed. It functions by preventing the RNA-polymerase enzyme in the bacillus from growing. RMP has been used to treat leprosy since 1963. Most of the bacilli become non-viable after a few days of therapy, and its use is crucial in all clinical types of leprosy. Clofazimine (CLF) is an iminophenazine dye . It has a mild bactericidal action, acting slowly on M. leprae and destroying 99% of the bacteria in approximately five months. Its efficacy is similar to DDS. CLF has an important anti-inflammatory action.
With an estimated heritability of up to 57%, family studies and community epidemiological surveys have amply established the significant role that host genetics plays in an individual's vulnerability to leprosy.
RAB32 is a low molecular weight G protein belonging to the Ras superfamily. It is necessary for the production of autophagic vacuoles and the control of autophagy's removal of aggregated proteins. Rab32 may play a similar role in the pathogenesis of leprosy, according to a recent study that found the protein controls the recruitment of cathepsin D to phagosomes containing Mycobacterium tuberculosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Leprosy Patients | Active comparator | Drug: DapsoneAbout 40 patients suffering from Leprosy and will treated by Multi drug therapy as ( dapsone _ clofazimine _ rifampcin) then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant At the end of third month therapy. |
| Group B: Healthy People | Active comparator | Drug: DapsoneAbout 10 Healthy People. no drugs used and then to assess the role of Rab 32 gene.by taking Two millimetres of venous blood from each participant |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients of both sexes with positive slit skin smear for m.leprae .
Key exclusion criteria (4 listed)
- Contraindications to Multi drug therapy :
- Patients with hypersensitivity to sulfa .
- Patients with hypersensitivity to clofazimine or rifampcin.
- pregnant or lactating women.
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 |
|---|---|---|
| DapsoneAlso: clofazimine, rifampcinTo evaluate the effect of the multi drug therapy in leprotic patients and their side effects and to assess the role of Rab 32 gene in leprosy prognosis and to know its association with the multi drug therapy. | Drug | Group A: Leprosy Patients, Group B: Healthy People |
Primary outcome
Treatment of leprosy
Time frame: 6 Months
About 40 of Participants With Treatment-Related Adverse Events as Assessed by measuring the of Rab 32 gene ( Rs2275606 ) polymorphism using real time PCR for Evaluation of the multi drug therapy on Leprotic Patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
Eisa Mohammed Hegazy, Assist. Prof study chair
Dermatology, Venereology and Andrology. Faculty of Medicine,South Valley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapsone in people with Leprosy and Mycobacterium Leprae Infection, run by South Valley 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lydia Atef Nassief, MSc (+201289416276, lydiaatef67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of leprosy (time frame: 6 Months). 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 11 Feb 2025.