Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Low Dose Naltrexone in Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250792
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sidra Khan, Jinnah Postgraduate Medical Centre

Tracking Information
First Submitted Date  ICMJE January 26, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
change in the severity of disease [ Time Frame: 12 weeks. ]
change in the percentage of area of body involved with disease (1 hand = 1%)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Low Dose Naltrexone in Psoriasis
Official Title  ICMJE Efficacy of Low Dose Naltrexone in Psoriasis; Clinical Trial in a Tertiary Care Hospital of Karachi.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Naltrexone Pill
role of low dose naltrexone in patients affected with psoriasis
Other Name: low dose naltrexone
Study Arms  ICMJE Experimental: single arm
Low dose naltrexone was prescribed to the patients affected with psoriasis.
Intervention: Drug: Naltrexone Pill
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2020)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250792
Other Study ID Numbers  ICMJE NO.F.2-81/2018-GENL/9009/JPMC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sidra Khan, Jinnah Postgraduate Medical Centre
Study Sponsor  ICMJE Jinnah Postgraduate Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rabia Ghafoor, FCPS Jinnah postgraduate medical centre, Karachi
PRS Account Jinnah Postgraduate Medical Centre
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP