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

NCT ID: NCT00640614

Last Updated: 2020-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-10-31

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.

Conditions

Contact Dermatitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Sensitives

Subjects with a clinical history and positive patch test (current or previous) to any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP

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.

Consecutives

Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP

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.

Interventions

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

Polyvinylpyrrolidone (PVP; excipient 1) Hydrocortisone-17-butyrate, 0.020 mg/cm2 in PVP Hydroxypropylcellulose (HPC; excipient 2) MDBGN, 0.0055 mg/cm2 in PVP Bacitracin, 0.60 mg/cm2 in HPC Gold sodium thiosulfate, 0.075 mg/cm2 in HPC Parthenolide, 0.0030 mg/cm2 in PVP Disperse Blue 106, 0.050 mg/cm2 in PVP Bronopol, 0.25 mg/cm2 in PVP

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

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

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allerderm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evy Paulsen, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Joseph Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists PSC

Luz Fonacier, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University

Donald V Belsito, MD

Role: PRINCIPAL_INVESTIGATOR

American Dermatology Associates

Jerri Hoskyn, MD

Role: PRINCIPAL_INVESTIGATOR

Rivery City Dermatology

Sandy Skotnicki-Grant, MD

Role: PRINCIPAL_INVESTIGATOR

Bay Dermatology Centre

Locations

River City Dermatology

Little Rock, Arkansas, United States

American Dermatology Associates

Shawnee Mission, Kansas, United States

Dermatology Specialists PSC

Louisville, Kentucky, United States

Winthrop University Hospital

Mineola, New York, United States

Odense University Hospital

Odense C, , Denmark

Countries

United States; Denmark

Other Identifiers

2008-000168-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WIRB Pr. No.: 20080089

Identifier Type: OTHER

Identifier Source: secondary_id

Mekos 07 7P3.2 301

Identifier Type: -

Identifier Source: org_study_id