An open single centre evaluation of the reactivity of the T.R.U.E TestTM Quaternium-15 patch and a real use exposure in subjects known to be allergic to Quaternium-15.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002987-27-DK

Enrollment

Registered

2005-07-20

Start date

2005-09-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Diagnosis of Allergic Contact Dermatitis

Interventions

Product Name: TRUE Test Pharmaceutical Form: Cutaneous stick INN or Proposed INN: Quaternium-15 CAS Number: 4080-31-3 Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Positive pre-test reaction to Quaternium-15 within the previous 5 years. 2. Age = 18 years. 3. Verbal and written informed consent. 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area. 2. Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days. 3. Treatment with UV-light during the latest 3 weeks. 4. Widespread active dermatitis or dermatitis on test area. 5. Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period. 6. Patients not able to cooperate. 7. Participation in other clinical studies during the study period and 3 weeks prior to study start.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the reactivity of the Quaternium-15 patch (T.R.U.E TestTM) and a topically applied product containing quaternium-15.;Secondary Objective: To evaluate if the subjects are cleared from the reactions at the safety visit (after 3 weeks). ;Primary end point(s): To compare the reactivity of the Quaternium-15 patch (T.R.U.E TestTM) and a topically applied product containing quaternium-15.	—

Measure

Time frame

Main Objective: To compare the reactivity of the Quaternium-15 patch (T.R.U.E TestTM) and a topically applied product containing quaternium-15.;Secondary Objective: To evaluate if the subjects are cleared from the reactions at the safety visit (after 3 weeks). ;Primary end point(s): To compare the reactivity of the Quaternium-15 patch (T.R.U.E TestTM) and a topically applied product containing quaternium-15.

—

Countries

Denmark

Outcome results

None listed

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