Official Title: “Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol”

We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens.

Study Type: Interventional

Study Design: Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary endpoint:

The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on: - Calculated concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens. - Calculated sensitivity and specificity for T.R.U.E. Test Panel 3.2 allergens.

Secondary endpoint:

To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives").

Evaluations will be based on: - The frequency and characterization of late and/or persistent reactions, tape-induced irritation at the test site, incomplete panel adhesion, and subject-reported sensations of itching or burning during the test period. - The frequency of adverse events and serious adverse events.

Primary:

• The performance of each allergen will be evaluated based on: Calculating concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens and calculated sensitivity and specificity. End of Study No

Secondary:

• Evaluations will be based on: Frequency and characterization of late and/or persistent reactions, tape-induced irritation, incomplete panel adhesion, and subject-reported sensations of itching or burning and the frequency of adverse events. End of study No

Inclusion Criteria:

• Consecutive subjects must report symptoms and/or history consistent with allergic contact dermatitis to at least one of the allergens tested in the study (i.e., subjects are visiting the clinic/physician to diagnose, treat or resolve this condition).
• Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
• Gold sodium thiosulfate
• Methyldibromoglutaronitrile (alone or with phenoxyethanol)
• Bacitracin
• Bronopol
• Disperse blue 106 (alone or with Disperse blue 124)
• Parthenolide (or Compositae mix)
• Hydrocortisone-17-butyrate
• All subjects must be adults over 18 years of age, and otherwise in good health.
• Premenopausal female subjects with childbearing potential must consent to a urine pregnancy test; urine 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 corticosteroid treatment during the last 7 days before visit 1 on or near the test area.
• Systemic treatment with corticosteroids or other immunosuppressants during the last 7 days.before visit 1.
• Subjects currently receiving (or received in the 21 days before visit 1) other investigational drugs, treatments or devices, or participating in another clinical study.
• Treatment with ultraviolet (UV) light (including tanning) during the 21 days before visit
• 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).

Lead Sponsor: Allerderm

River City Dermatology

Little Rock Arkansas 72205 United States

American Dermatology Associates

Shawnee Kansas 66216 United States

Dermatology Specialists PSC

Louisville Kentucky 40202-1864 United States

Winthrop University Hospital

Mineola New York 11501 United States

Bay Dermatology Centre

Toronto Ontario M5G 1N8 Canada

Odense University Hospital

Odense C  DK-5000 Denmark

Overall Clinical Trial Officials and Contacts

Evy Paulsen, M.D., Ph.D Principal Investigator Odense University Hospital  

Overall Contact: Erin L Oliver, BA +1 602-225-0595 eoliver@smarthealth.com

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640614

Study ID Number: Mekos 07 7P3.2 301

ClinicalTrials.gov Identifier: NCT00640614

Health Authority: United States: Food and Drug Administration