PsoriasisPhase 1NCT04250792
Efficacy of Low Dose Naltrexone in Psoriasis
A Phase 1 study testing Naltrexone Pill in people with Psoriasis, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
Objective of the study is to determine the efficacy of low dose naltrexone in the patients of psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center, Karachi. Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Naltrexone Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 30 Sep 2019
- Phase
- 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 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- minimum age 13 years
- maximum age 60 years
- both males and females affected with mild, moderate and severe psoriasis.
Who cannot join
- hypertension
- cardiovascular disorders
- pregnancy
- lactation
- renal failure
- liver failure
- hypersensitivity to drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
Objective of the study is to determine the efficacy of low dose naltrexone in the patients of psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center, Karachi. All patients with mild, moderate and severe psoriasis with age above 13 years without any co-morbid, were prescribed tablet Naltrexone 6 mg daily after assessing PASI, BSA and DLQI scores before starting treatment. Patients were called monthly for follow up to monitor lipid profiles and liver function tests. After 3 months of treatment, PASI, BSA and DLQI scores were assessed again. The results were significant when analysed with paired t test in SPSS 23.
Read the detailed description
Psoriasis is a chronic T-cell mediated disorder. The activated T cell secretes cytokines that result in keratinocytes hyper-proliferation and abnormal differentiation. These cytokines result in chemo-taxis of neutrophils and lymphocytes in skin. It is a multi-factorial disease. Individual has genetic susceptibility for psoriasis, but environmental factors trigger the disease like infections, drugs, cold, trauma and stress. It is a multi-system disease but mainly affects skin, nails and joints. It impacts adversely on patients' quality of life, causes embarrassment, limitation in clothing choice, psychological distress which further aggravates the disease. It impacts economically due to off days from work as well. In its most common form, it presents as salmon pink plaques, covering with thick silver scales, mostly on scalp, trunk, buttocks and external surfaces of limbs.
In the management of psoriasis, there are multiple treatment options which includes topical, systemic and photo-therapy. But all have their side effects and contraindication. Low dose naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and anti-inflammatory properties for various dermatological disorders including psoriasis. In this study, the effectiveness of low dose naltrexone in cases of psoriasis was assessed.
The study was conducted in the department of dermatology in Jinnah Postgraduate Medical Centre, Karachi, after receiving approval letter from the institutional ethical and research committee of the hospital.Forty two patients were selected of either gender with age ranging from 13-60 years, after excluding hypertension, cardiovascular disorders, pregnancy and lactation. The procedure has been explained to each patient \& written consent has been taken. Before prescribing LDN treatment, Psoriasis area and severity index(PASI), Body surface area(BSA) and Dermatology life quality index(DLQI) has been calculated. Each case has prescribed tablet naltrexone 6mg daily after checking all baselines investigations of complete blood picture , renal and liver function profiles. The cases were asked to follow up monthly to observe patient compliance, response of medicine and its side effects. After 3 months of treatment, PASI, BSA and DLQI have been calculated to assess the effectiveness of treatment.
PASI score is used to measure the severity and extent of disease, in terms of intensities of erythema, induration and scaling of lesion and the area of body involved with disease.
Body surface area (BSA) is calculated through 'rule of nine' which is a convenient and rapid method of estimating the extent of body surface area affected with disease. If BSA is <3%, 3-10%, or >10%, it is categorized as mild, moderate and severe disease, respectively.
The dermatology life quality index is a simple questionnaire, that consists of 10 questions to assess the impact of disease and its treatment on daily activities and the impact on the social behavior of the patients. DLQI scores has been interpreted in terms of effect of disease on patients' life as follows:
- 0-1 = No effect
- 2-5 = Small effect
- 6-10 = Moderate effect
- 11-20 = Very large effect
- 21-30 = Extremely large effect After 3 months, all three scores were assessed again to observe the effectiveness of treatment. The evaluation was done by SPSS version 23. The side effects were assessed regarding nausea, headache, decreased appetite, dizziness, palpitation, liver enzymes level, renal and complete blood profiles.
- Conditions
- Psoriasis
- Being tested
- Naltrexone Pill
- Keywords
- Low dose naltrexone, psoriasis, Psoriasis area severity index
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone PillDrug
Also called low dose naltrexone
role of low dose naltrexone in patients affected with psoriasis
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Low dose naltrexone was prescribed to the patients affected with psoriasis. Receives: Drug: Naltrexone Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the severity of disease
change in the percentage of area of body involved with disease (1 hand = 1%)
Measured: 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start1 Jan 2019
- Primary completion31 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sidra Khan, Jinnah Postgraduate Medical Centre
- Investigators
- Rabia Ghafoor, FCPS, Study director, Jinnah postgraduate medical centre, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250792
- Sponsor's protocol ID
- NO.F.2-81/2018-GENL/9009/JPMC
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2020
- Last updated
- 31 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
PubMed 30909615Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.
PubMed 31123647Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943.
PubMed 30937241
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
- ClinicalTrials.gov ID
- NCT04250792
- Acronym / sponsor ID
- NO.F.2-81/2018-GENL/9009/JPMC
- Conditions
- Psoriasis
- Keywords
- Low dose naltrexone, psoriasis, Psoriasis area severity index
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Jan 2020 (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.
Objective of the study is to determine the efficacy of low dose naltrexone in the patients of psoriasis, which is a chronic relapsing and remitting disease. A non-randomized clinical trial was carried out in the Department of dermatology in Jinnah Postgraduate Medical Center, Karachi. All patients with mild, moderate and severe psoriasis with age above 13 years without any co-morbid, were prescribed tablet Naltrexone 6 mg daily after assessing PASI, BSA and DLQI scores before starting treatment. Patients were called monthly for follow up to monitor lipid profiles and liver function tests. After 3 months of treatment, PASI, BSA and DLQI scores were assessed again. The results were significant when analysed with paired t test in SPSS 23.
Detailed description
Psoriasis is a chronic T-cell mediated disorder. The activated T cell secretes cytokines that result in keratinocytes hyper-proliferation and abnormal differentiation. These cytokines result in chemo-taxis of neutrophils and lymphocytes in skin. It is a multi-factorial disease. Individual has genetic susceptibility for psoriasis, but environmental factors trigger the disease like infections, drugs, cold, trauma and stress. It is a multi-system disease but mainly affects skin, nails and joints. It impacts adversely on patients' quality of life, causes embarrassment, limitation in clothing choice, psychological distress which further aggravates the disease. It impacts economically due to off days from work as well. In its most common form, it presents as salmon pink plaques, covering with thick silver scales, mostly on scalp, trunk, buttocks and external surfaces of limbs.
In the management of psoriasis, there are multiple treatment options which includes topical, systemic and photo-therapy. But all have their side effects and contraindication. Low dose naltrexone(LDN) is an attractive emergent therapy with analgesic, anti-pruritic and anti-inflammatory properties for various dermatological disorders including psoriasis. In this study, the effectiveness of low dose naltrexone in cases of psoriasis was assessed.
The study was conducted in the department of dermatology in Jinnah Postgraduate Medical Centre, Karachi, after receiving approval letter from the institutional ethical and research committee of the hospital.Forty two patients were selected of either gender with age ranging from 13-60 years, after excluding hypertension, cardiovascular disorders, pregnancy and lactation. The procedure has been explained to each patient \& written consent has been taken. Before prescribing LDN treatment, Psoriasis area and severity index(PASI), Body surface area(BSA) and Dermatology life quality index(DLQI) has been calculated. Each case has prescribed tablet naltrexone 6mg daily after checking all baselines investigations of complete blood picture , renal and liver function profiles. The cases were asked to follow up monthly to observe patient compliance, response of medicine and its side effects. After 3 months of treatment, PASI, BSA and DLQI have been calculated to assess the effectiveness of treatment.
PASI score is used to measure the severity and extent of disease, in terms of intensities of erythema, induration and scaling of lesion and the area of body involved with disease.
Body surface area (BSA) is calculated through 'rule of nine' which is a convenient and rapid method of estimating the extent of body surface area affected with disease. If BSA is <3%, 3-10%, or >10%, it is categorized as mild, moderate and severe disease, respectively.
The dermatology life quality index is a simple questionnaire, that consists of 10 questions to assess the impact of disease and its treatment on daily activities and the impact on the social behavior of the patients. DLQI scores has been interpreted in terms of effect of disease on patients' life as follows:
- 0-1 = No effect
- 2-5 = Small effect
- 6-10 = Moderate effect
- 11-20 = Very large effect
- 21-30 = Extremely large effect After 3 months, all three scores were assessed again to observe the effectiveness of treatment. The evaluation was done by SPSS version 23. The side effects were assessed regarding nausea, headache, decreased appetite, dizziness, palpitation, liver enzymes level, renal and complete blood profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Naltrexone PillLow dose naltrexone was prescribed to the patients affected with psoriasis. |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- minimum age 13 years
- maximum age 60 years
- both males and females affected with mild, moderate and severe psoriasis.
Key exclusion criteria (7 listed)
- hypertension
- cardiovascular disorders
- pregnancy
- lactation
- renal 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 |
|---|---|---|
| Naltrexone PillAlso: low dose naltrexonerole of low dose naltrexone in patients affected with psoriasis | Drug | single arm |
Primary outcome
change in the severity of disease
Time frame: 12 weeks.
change in the percentage of area of body involved with disease (1 hand = 1%)
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 31 Jan 2020.
- Background: PubMed 30909615Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
- Background: PubMed 31123647Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.
- Results publication: PubMed 30937241Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rabia Ghafoor, FCPS study director
Jinnah postgraduate medical centre, Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naltrexone Pill in people with Psoriasis, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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 7 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 31 Jan 2020. 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 Pakistan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
change in the severity of disease (time frame: 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250792, which also lists 3 linked publications.
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 31 Jan 2020.