VALUTATION OF AN ORAL HYPOSENSITIZATION TREATMENT IN PATIENTS WITH ALLERGIC CONTACT DERMATITIS TO NICKEL SULPHATE - TIONICKEL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004791-12-IT

Enrollment

Registered

2007-01-10

Start date

2006-06-30

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic contact dermatitis to nickel sulphate MedDRA version: 6.1 Level: PT Classification code 10012442

Interventions

Product Name: nickel sulphate Pharmaceutical Form: Capsule, hard Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age between 18 and 60 years old Dermatitis for at least 4 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy Irritant contact dermatitis Patients in therapy with corticosteroids and FANS Patients with other relevant diseases

Design outcomes

Primary

Measure	Time frame
Main Objective: Clinical evaluation of efficacy of oral hyposensibilization treatment to nickel sulphate to decrease allergic contact dermatitis;Secondary Objective: Evaluation of immunological pattern induced by therapy Evaluation of safety and tolerability of therapy;Primary end point(s): Response rate	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026