Efficacy of Low Dose Naltrexone in Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Naltrexone Pill

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Jinnah Postgraduate Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm; Low dose naltrexone was prescribed to the patients affected with psoriasis.	Drug: Naltrexone Pill; role of low dose naltrexone in patients affected with psoriasis; Other Names: low dose naltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the severity of disease	change in the percentage of area of body involved with disease (1 hand = 1%)	12 weeks.

Collaborators and Investigators

• Sponsor: Jinnah Postgraduate Medical Centre
• Investigators: Study Director: Rabia Ghafoor, FCPS, jinnah postgraduate medical centre, karachi

Publications and helpful links

General Publications

• Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.
• Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.
• Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): September 30, 2019

Study Registration Dates

• First Submitted: January 26, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: psoriasis; Low dose naltrexone; Psoriasis area severity index
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: NO.F.2-81/2018-GENL/9009/JPMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No