E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of Allergic Contact Dermatitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056265 |
E.1.2 | Term | Allergic contact dermatitis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the diagnostic performance of 3 concentrations of disperse blue 106 and 4 concentrations of Bronopol in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen (“sensitives”). |
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E.2.2 | Secondary objectives of the trial |
To compare the safety of 3 concentrations of disperse blue 106 and 4 concentrations of Bronopol in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test (current or previous) to the corresponding reference petrolatum allergen (“sensitives”). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
*Current or previous symptoms and/or history consistent with allergic contact dermatitis, and positive patch test (within the past 5 years) to Bronopol ORCurrent or previous symptoms and/or history consistent with allergic contact dermatitis, and a positive patch test (within the past 5 years) to disperse blue 106 or disperse blue 106/124 allergen mix. *All subjects must be adults (18 years of age or older) and otherwise in good health. *Premenopausal female subjects must consent to a urine pregnancy test; results must be negative for study inclusion. *Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations. |
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E.4 | Principal exclusion criteria |
*Subjects unable to meet inclusion requirements.· Women who are breastfeeding or pregnant. *Topical treatment during the last 7 days with corticosteroids or other immunosuppressive agents on or near the test area. *Systemic treatment during the last 7 days with corticosteroids (equivalent to > 10 mg prednisone) or other immunosuppressive agents. *Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks. *Acute dermatitis outbreak or dermatitis on or near the test area on the back. *Subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity). *Subject participation in clinical trials of investigational drugs, treatments or devices other than TRUE TEST during this study or 3 weeks prior to inclusion in this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Determination of optimal test allergen concentration as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects; frequency of positive, negative, doubtful and irritant reactions for each allergen and concentration; and overall concordance and discordance as compared to the reference petrolatum allergens.
Secondary Endpoint: Frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen and concentration. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Reference Allergens (Corresponding allergen in petrolatum) |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |