Efficacy of Low Dose Naltrexone in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Naltrexone Pill
Sponsored by

About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Low dose naltrexone, psoriasis, Psoriasis area severity index
Eligibility Criteria
Inclusion Criteria:
- minimum age 13 years
- maximum age 60 years
- both males and females affected with mild, moderate and severe psoriasis.
Exclusion Criteria:
- hypertension
- cardiovascular disorders
- pregnancy
- lactation
- renal failure
- liver failure
- hypersensitivity to drug
Sites / Locations
- Jinnah postgraduate medical centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Low dose naltrexone was prescribed to the patients affected with psoriasis.
Outcomes
Primary Outcome Measures
change in the severity of disease
change in the percentage of area of body involved with disease (1 hand = 1%)
Secondary Outcome Measures
Full Information
NCT ID
NCT04250792
First Posted
January 26, 2020
Last Updated
January 29, 2020
Sponsor
Jinnah Postgraduate Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT04250792
Brief Title
Efficacy of Low Dose Naltrexone in Psoriasis
Official Title
Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinnah Postgraduate Medical Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Low dose naltrexone, psoriasis, Psoriasis area severity index
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Low dose naltrexone was prescribed to the patients affected with psoriasis.
Intervention Type
Drug
Intervention Name(s)
Naltrexone Pill
Other Intervention Name(s)
low dose naltrexone
Intervention Description
role of low dose naltrexone in patients affected with psoriasis
Primary Outcome Measure Information:
Title
change in the severity of disease
Description
change in the percentage of area of body involved with disease (1 hand = 1%)
Time Frame
12 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
minimum age 13 years
maximum age 60 years
both males and females affected with mild, moderate and severe psoriasis.
Exclusion Criteria:
hypertension
cardiovascular disorders
pregnancy
lactation
renal failure
liver failure
hypersensitivity to drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Ghafoor, FCPS
Organizational Affiliation
Jinnah postgraduate medical centre, Karachi
Official's Role
Study Director
Facility Information:
Facility Name
Jinnah postgraduate medical centre
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75510
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30909615
Citation
Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
Results Reference
background
PubMed Identifier
31123647
Citation
Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.
Results Reference
background
PubMed Identifier
30937241
Citation
Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943.
Results Reference
result
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Efficacy of Low Dose Naltrexone in Psoriasis
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