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

Sponsored by:	Allerderm
Information provided by:	Allerderm
ClinicalTrials.gov Identifier:	NCT00640250

Purpose

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").

Condition	Intervention	Phase
Contact Dermatitis	Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens	Phase II

Drug Information available for: 2-Bromo-2-nitropropane-1,3-diol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
Official Title:	Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Bronopol and Disperse Blue 106 Dose Response Study

Further study details as provided by Allerderm:

Primary Outcome Measures:

Determination of optimal test concentration for Disperse Blue 106 and Bronopal as the lowest concentration eliciting either +1 or +2 positive reactions in 70-90% of sensitive subjects. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of irritation, late/persistent reactions, tape reactions, subject-reported itching or burning, and adverse events for each allergen and concentration. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.

Arms

Assigned Interventions

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

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640250

Contacts

Contact: Kim M Sullivan, BA	+1 602-225-0595 ext 274	sullivan@smarthealth.com
Contact: Heather Schutten	+1 602-225-0595 ext 302	hschutte@smarthealth.com

Locations

United States, Kentucky
Dermatology Specialists PSC	Recruiting
Louisville, Kentucky, United States, 40202-1864
Contact: Jennifer Goyne 502-583-7546 ext 158 dermresearch@msn.com
Contact: Lynn Fowler +1 502-583-7546 lynnmfowler@msn.com
Principal Investigator: Joseph Fowler, MD
Denmark
Odense University Hospital	Recruiting
Odense C, Denmark, DK-5000
Contact: Evy Paulsen, MD, Ph.D +45 65 41 27 08 Evy.Paulsen@ouh.regionsyddanmark.dk
Contact: Klaus E Andersen, MD, Ph.D +45 65 41 27 00 Klaus.Ejner.Andersen@ouh.regionsyddanmark.dk
Principal Investigator: Evy Paulsen, MD, Ph.D
Sub-Investigator: Klaus E Andersen, MD, Ph.D
Sub-Investigator: Charlotte G Mørtz, MD, Ph.D

Sponsors and Collaborators

Allerderm

Investigators

Principal Investigator:	Evy Paulsen, M.D., Ph.D	Odense University Hospital
Principal Investigator:	Joseph Fowler, MD	Dermatology Specialists PSC

More Information

No publications provided

Responsible Party:	Allerderm ( Kim M Sullivan/ Study Coordinator )
Study ID Numbers:	Mekos 07 2P3.2 201, BB-IND#: 13546, Eudra CT#: 2007-007130-19, WIRB Pr. No.: 20072233
Study First Received:	March 3, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00640250 History of Changes
Health Authority:	United States: Food and Drug Administration; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee

Keywords provided by Allerderm:

Dermatitis, Contact, Bronopol, Disperse Blue 106

Study placed in the following topic categories:

Skin Diseases
Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Skin Diseases
Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

ClinicalTrials.gov processed this record on May 06, 2009