Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Dose Response

NCT ID: NCT00640250

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-09-30

Brief Summary

We propose a prospective, multi-center, double-blind, randomized study comparing the diagnostic performance (primary) and safety (secondary) of 3 concentrations of Disperse blue 106 and 4 concentrations of Bronopol in 40 adult subjects (20 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").

Detailed Description

Primary endpoint:

To evaluate the diagnostic performance of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

• Determination of the lowest concentration eliciting positive skin reactions (+1 or +2) in 70-90% of sensitive subjects.
• Frequency of positive, negative, doubtful and irritant reactions for each allergen and tested concentration.
• Concordance/discordance as compared to the corresponding reference petrolatum allergen.

Secondary endpoint:

To evaluate the safety of Disperse blue 106 and Bronopol T.R.U.E. Test allergens in 20 adult subjects per allergen with a clinical history of contact dermatitis and a positive patch test to the respective reference allergen. Evaluations will include:

• The frequency of tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning.
• The frequency and characterization of adverse events and serious adverse events.
• The frequency and characterization of late and/or persistent reactions.

Conditions

Contact Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sensitives

Subjects with a clinical history and positive patch test (current or previous) to either Disperse Blue 106 or Bronopol. Subjects must otherwise be healthy and fulfill entry criteria.

Group Type: EXPERIMENTAL

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Intervention Type: BIOLOGICAL

Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2

Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Interventions

T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens

Disperse blue 106 in PVP, 0.15 mg/cm2 Disperse blue 106 in PVP, 0.050 mg/cm2 Disperse blue 106 in PVP, 0.017 mg/cm2 PVP Negative Control Bronopol in PVP, 0.75 mg/cm2 Bronopol in PVP, 0.50 mg/cm2 Bronopol in PVP, 0.25 mg/cm2 Bronopol in PVP, 0.125 mg/cm2

Test patches, with allergens, are placed at day one and removed 48 hours later. The duration of the study lasts 21 days. However, the subject is only exposed to the study allergens for 48 hours.

Intervention Type: BIOLOGICAL

Other Intervention Names

T.R.U.E. TEST® Skin Patch Test: Panel 3.2

Eligibility Criteria

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 OR Current 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.

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 T.R.U.E. Test during this study or 3 weeks prior to inclusion in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evy Paulsen, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists PSC

Locations

Dermatology Specialists PSC

Louisville, Kentucky, United States

Odense University Hospital

Odense C, , Denmark

Countries

United States; Denmark

Other Identifiers

2007-007130-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WIRB Pr. No.: 20072233

Identifier Type: OTHER

Identifier Source: secondary_id

Mekos 07 2P3.2 201

Identifier Type: -

Identifier Source: org_study_id