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

NCT00640250 | Completed Phase 2 Results

• 3 other identifiers: Mekos 07 2P3.2 2012007-007130-19WIRB Pr. No.: 20072233
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

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").

Conditions

Contact Dermatitis

Keywords

Dermatitis, Contact, Bronopol, Disperse Blue 106

Outcome Measures

Primary Outcomes (6)

• Diagnostic Performance: Optimal Test Allergen Concentration

  Lowest concentration eliciting 1+ or 2+ positive reactions in 70-90% of subjects

  Visits 3-5: 3-21 days after application

• Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

  Percentage (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 3- all subjects

  Visit 3: 3 days after application

• Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

  Percent (including confidence intervals) of subjects who elicited positive, negative, doubtful and irritant reactions to disperse blue at visit 4- all subjects

  Visit 4: 7 days after application

• Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

  Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 3- all subjects

  Visit 3: 3 days after application

• Frequency of Positive, Negative, Doubtful and Irritant Reactions for Each Allergen and Concentration

  Percentage (including confidence intervals) of subjects who exhibited positive, negative, doubtful and irritant reactions to bronopol at visit 4- all subjects

  Visit 4: 7 days after application

• Concordance Between Investigational Allergen and Reference Allergen

  Concordance between disperse blue or bronopol and the respective reference petrolatum allergen

  Visit 5: 21 days after patch application

Secondary Outcomes (2)

• Frequency of Irritation (Tape Reactions), Late/Persistent Reactions and Subject-reported Itching or Burning

  Day 2-21

• Adverse Events

  Days 0-21

Study Arms (1)

Sensitives

EXPERIMENTAL

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.

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

Interventions

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

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

Sensitives

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Informed consent must be signed and understood by each subject, and consistent with all institutional, local and national regulations.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Allerderm: lead

Study Sites (2)

Dermatology Specialists PSC

Louisville, Kentucky, 40202-1864, United States

Location

Odense University Hospital

Odense C, DK-5000, Denmark

Location

MeSH Terms

Conditions

Dermatitis, Contact; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Limitations and Caveats

There were no limitations or caveats which led to unreadable or uninterpretable data.

Results Point of Contact

• Title: Evy Paulsen, MD
• Organization: Institute of Clinical Research, Department of Dermoto Venerology and Allergy Center

+45 65 41 27 08

Study Officials

• Evy Paulsen, M.D., Ph.D

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Joseph Fowler, MD

  Dermatology Specialists PSC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 21, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 9, 2018
• Results First Posted: April 9, 2018

Record last verified: 2018-04

Locations

DK (1); US (1)