Quality of Life in Systemic Nickel Allergy Syndrome

CompletedOBSERVATIONAL
Enrollment

52

Participants

Timeline

Start Date

March 31, 2015

Primary Completion Date

April 30, 2019

Study Completion Date

May 30, 2019

Conditions
Systemic Nickel Allergy SyndromeQuality of Life
Interventions
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.

Trial Locations (1)

00168

Catholic University of Sacred Heart, Roma

All Listed Sponsors
lead

Catholic University of the Sacred Heart

OTHER

NCT03731494 - Quality of Life in Systemic Nickel Allergy Syndrome | Biotech Hunter | Biotech Hunter