Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy

Phase 3

Completed

Conditions: Contact Dermatitis

Registration Number: NCT00640614

Lead Sponsor: Allerderm

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 235

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance: Sensitivity and Specificity: Disperse Blue	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Concordance	Visit 5: 21 days after patch application	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen bronopol and the reference allergen.
Diagnostic Performance: Sensitivity and Specificity: Methyldibromo-glutaronitrile	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Concordance Between Investigational Allergen and Reference Allergen at Day 21	Visit 5: 21 days after patch application	Concordance: Percentage of subjects who responded positively to T.R.U.E. Test allergen gold sodium thiosulfate and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Gold Sodium Thiosulfate	Visit 5: 21 days after patch application	Percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Bacitracin	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Bronopol	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Hydrocortisone-17-butyrate	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen
Diagnostic Performance: Sensitivity and Specificity: Parthenolide	Visit 5: 21 days after patch application	The percentage of subjects with positive (sensitivity) and negative (specificity) results to the investigational allergen and the reference allergen

Secondary Outcome Measures

Name	Time	Method
Safety Evaluations: All T.R.U.E. Test Allergens	Day 2: 48 hours after application	Safety Evaluations: Number of participants who experienced Tape Irritation, Itching or Burning and measure of how well patches adhered to the skin.
Persistent Reactions: All T.R.U.E. Test Allergens	initially occur 2-4 days after application and last through 7-21days after patch application	Number of Subjects who exhibited Persistent Reactions (reactions that initially occur at 2-4 days after application and persist through 7-21 days after application)
Late Reactions: All T.R.U.E. Test Allergens	7-10 days after patch application	Number of subjects who exhibited Late Reactions (reactions that occur at 7-10 days after application).

Trial Locations

Locations (5): Dermatology Specialists PSC
🇺🇸
Louisville, Kentucky, United States
Winthrop University Hospital
🇺🇸
Mineola, New York, United States
American Dermatology Associates
🇺🇸
Shawnee Mission, Kansas, United States
Odense University Hospital
🇩🇰
Odense C, Denmark
River City Dermatology
🇺🇸
Little Rock, Arkansas, United States