Efficacy of Low Dose Naltrexone in Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Naltrexone Pill
Intervention type(s): Drug
Intervention description(s): role of low dose naltrexone in patients affected with psoriasis
Other intervention name(s): low dose naltrexone
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low dose naltrexone; psoriasis; Psoriasis area severity index