Efficacy of Low Dose Naltrexone in Psoriasis

NCT04250792 | Completed Phase 1

• 1 other identifier: NO.F.2-81/2018-GENL/9009/JPMC
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Low dose naltrexone; psoriasis; Psoriasis area severity index

Outcome Measures

Primary Outcomes (1)

• change in the severity of disease

  change in the percentage of area of body involved with disease (1 hand = 1%)

  12 weeks.

Study Arms (1)

single arm

EXPERIMENTAL

Low dose naltrexone was prescribed to the patients affected with psoriasis.

Drug: Naltrexone Pill

Interventions

Naltrexone Pill DRUG

role of low dose naltrexone in patients affected with psoriasis

Also known as: low dose naltrexone

single arm

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• minimum age 13 years
• maximum age 60 years
• both males and females affected with mild, moderate and severe psoriasis.

You may not qualify if:

• hypertension
• cardiovascular disorders
• pregnancy
• lactation
• renal failure
• liver failure
• hypersensitivity to drug

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

Jinnah postgraduate medical centre

Karachi, Sindh, 75510, Pakistan

Location

Related Publications (3)

• Rendon A, Schakel K. Psoriasis Pathogenesis and Treatment. Int J Mol Sci. 2019 Mar 23;20(6):1475. doi: 10.3390/ijms20061475.

  PMID: 30909615 BACKGROUND

• Zashin S. Sjogren's Syndrome: Clinical Benefits of Low-dose Naltrexone Therapy. Cureus. 2019 Mar 11;11(3):e4225. doi: 10.7759/cureus.4225.

  PMID: 31123647 BACKGROUND

• Beltran Monasterio EP. Low-dose Naltrexone: An Alternative Treatment for Erythrodermic Psoriasis. Cureus. 2019 Jan 23;11(1):e3943. doi: 10.7759/cureus.3943.

  PMID: 30937241 RESULT

MeSH Terms

Conditions

Psoriasis

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Rabia Ghafoor, FCPS

  Jinnah postgraduate medical centre, Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: January 31, 2020
• Study Start: January 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)