Quality of Life in Systemic Nickel Allergy Syndrome
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|ClinicalTrials.gov Identifier: NCT03731494|
Recruitment Status : Recruiting
First Posted : November 6, 2018
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment|
|Systemic Nickel Allergy Syndrome Quality of Life||Biological: Nickel oral hyposensitization treatment|
Nickel (Ni) is a nutritionally essential metal widely distributed in the environment, and it has been reported to be one of the most common causes of allergic contact dermatitis (ACD), affecting nearly 15-20% of the general population. As known, Ni-hypersensitivity can induce less frequently also respiratory allergy (RA) and in approximately 20% of Ni-ACD patients cause a more complex condition termed Systemic Nickel Allergy Syndrome (SNAS). It is characterized by a combination of cutaneous (in regions without direct nickel contact) and extracutaneous gastrointestinal symptoms, after the ingestion of Ni-rich foods, especially vegetables. Then, a low-Ni diet, following positive patch tests, represents a effective diagnostic and therapeutic tool in the control of systemic manifestations, determining a significant clinical improvement.
It is known that Nickel oral hyposensitization treatment (NiOHT) is a effective approach for the management of Ni allergy, especially in a subset of patients with SNAS, inducing immunological and clinical tolerance to metal at the doses normally taken with the diet.
Although a large number of clinical trials focused on the health-related quality of life (HRQoL) in allergic disease, the expectations, the needs and the psychosocial characteristics of patients affected by SNAS are limited and no data exist pre- and post-treatment and specifically with NiOHT. Given the high safety profile and beneficial effects of immunotherapy on HRQoL of patients with allergic rhinitis, we hypothesized similar positive results even after oral Ni desensitization.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Quality of Life Assessment Before and After Hyposensitization Treatment in Systemic Nickel Allergy Syndrome|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
Nickel oral hyposensitization treatment
The patients take capsules at different doses in nickel content until reaching the maximum dose of 1.5 mcg per week for a total of 12 months.
Biological: Nickel oral hyposensitization treatment
Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.
Other Name: NiOHT - TIO Nickel
- QoL: Short-Form 36-Item Health Survey (SF-36v2) [ Time Frame: Change from baseline index at 12 months ]Short-Form 36-Item Health Survey (SF-36v2) is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively.
- QoL: Psychological General Well Being Index (PGWBI) [ Time Frame: Change from baseline index at 12 months ]The PGWBI consists of 22 questions, which deal with six factors (anxiety, depression, vitality, general health,self-control and well-being) constituting a global assessment.The response format is graded 1-6 (i.e. total range 22-132), with the highest value corresponding to optimal well-being.
- Psychological state: Minnesota Multiphasic Personality Inventory (MMPI-2) [ Time Frame: Baseline. ]The MMPI-2 questionnaire containing 567 items with 2 choices of answer ("true" or "false") in order to assess the main structural features of personality and emotional disorders.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731494
|Contact: Eleonora Nucera, MD,Profemail@example.com|
|Contact: Angela Rizzi, MD,PhDfirstname.lastname@example.org|
|Catholic University of Sacred Heart||Recruiting|
|Roma, Italy, 00168|
|Contact: Eleonora Nucera, MD,Prof 003930154965 email@example.com|
|Contact: Angela Rizzi, MD,PhD 003930154965 firstname.lastname@example.org|
|Sub-Investigator: Angela Rizzi, MD,PhD|
|Sub-Investigator: Alessia Di Rienzo, MD|
|Sub-Investigator: Riccardo Inchingolo, MD,PhD|
|Sub-Investigator: Domenico Schiavino, MD,Prof|
|Principal Investigator:||Eleonora Nucera, MD,Prof||Catholic University of Sacred Heart|
|Study Director:||Antonio Gasbarrini, MD,Prof||Catholic University of Sacred Heart|