Clinical trial NCT00640614: Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contact Dermatitis
Keywords: Dermatitis, Contact
Lead sponsor: Allerderm
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Concordance
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Bacitracin
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Parthenolide
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Disperse Blue
timeFrame: Visit 5: 21 days after patch application
measure: Diagnostic Performance: Sensitivity and Specificity: Bronopol
timeFrame: Visit 5: 21 days after patch application
Secondary outcomes:
measure: Safety Evaluations: All T.R.U.E. Test Allergens
timeFrame: Day 2: 48 hours after application
measure: Late Reactions: All T.R.U.E. Test Allergens
timeFrame: 7-10 days after patch application
measure: Persistent Reactions: All T.R.U.E. Test Allergens
timeFrame: initially occur 2-4 days after application and last through 7-21days after patch application
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: River City Dermatology
state: Arkansas
city: Shawnee Mission
country: United States
facility: American Dermatology Associates
state: Kansas
city: Louisville
country: United States
facility: Dermatology Specialists PSC
state: Kentucky
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Evy Paulsen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists PSC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Winthrop University
name: Luz Fonacier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Dermatology Associates
name: Donald V Belsito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rivery City Dermatology
name: Jerri Hoskyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bay Dermatology Centre
name: Sandy Skotnicki-Grant, MD
role: PRINCIPAL_INVESTIGATOR
References: