Evaluación de la eficacia clinica, seguridad y actividad farmacologica de UR-1505 en voluntarios con alergia a niquel: estudio aleatorizado, doble ciego, cruzado y con control activo

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005677-30-ES

Enrollment

Registered

2006-01-17

Start date

2006-02-10

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

Volunteers with nickel allergy

Interventions

Product Name: UR-1505 2% Product Code: UR-1505 Pharmaceutical Form: Ointment Current Sponsor code: UR-1505 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0.1- Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Volunteers with nickel allergy (4patch test) Age 18--55 years old Both sexes No relevant medical history No relevant physical examination Informed consent signed 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) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Drug, xantines or alcohol abuse Drug intake in the previous 48 hours Investigational drug intake in the 3 previous months Breast feeding or pregnanacy womwn Some relevant disease Not anticonceptival measures

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of UR-1505 in the treatment of nickel allergy;Secondary Objective: To evaluate the safety of the treatments;Primary end point(s): Evaluate the allergic reaction by the physician global scale on day 4	—

Countries

Spain

Outcome results

None listed

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