Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy - Full Text View

Sponsored by:	Allerderm
Information provided by:	Allerderm
ClinicalTrials.gov Identifier:	NCT00640614

Purpose

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.

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

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Bacitracin Bacitracin zinc Sodium thiosulfate Sodium hyposulfite Povidone Hydrocortisone 17-butyrate

U.S. FDA Resources

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

Further study details as provided by Allerderm:

Primary Outcome Measures:

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. [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	205
Study Start Date:	April 2008
Estimated Study Completion Date:	October 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 any of the seven allergens. Subjects must otherwise be healthy and fulfill entry criteria.	Biological: 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.
Consecutives: Experimental Subjects who are being seen for standard allergy patch testing, that are asked to participate in the study.	Biological: 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.

Arms

Assigned Interventions

Sensitives: Experimental

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.

Biological: 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.

Consecutives: Experimental

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

Biological: 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640614

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, Arkansas
River City Dermatology	Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Jerri Hoskyn, MD 501-228-4664 jhoskyn@rivercitydermatology.com
Principal Investigator: Jerri Hoskyn, MD
United States, Kansas
American Dermatology Associates	Recruiting
Shawnee, Kansas, United States, 66216
Contact: Donald V Belsito, MD 913-631-6330 dbelsito@kc.rr.com
Principal Investigator: Donald V Belsito, MD
United States, Kentucky
Dermatology Specialists PSC	Recruiting
Louisville, Kentucky, United States, 40202-1864
Contact: Lynn Fowler 502-583-7546 lynnmfowler@msn.com
Principal Investigator: Joseph Fowler, MD
United States, New York
Winthrop University Hospital	Recruiting
Mineola, New York, United States, 11501
Contact: Betsy Alicea-Pinnick, LPN 516-663-9582 BPinnick@Winthrop.org
Contact: Elena Crespo +1 516-663-9582 ecrespo@winthrop.org
Principal Investigator: Luz Fonacier, MD
Canada, Ontario
Bay Dermatology Centre	Not yet recruiting
Toronto, Ontario, Canada, M5G 1N8
Contact: Susan Flanagan, R.N.,CCRC +1 416-467-0123 sfclinicalcoordination@sympatico.ca
Contact: Sandy Skotnicki-Grant, MD 416-515-8808 sandyskotnicki@baydermatologycentre.com
Principal Investigator: Sandy Skotnicki-Grant, 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
Principal Investigator:	Luz Fonacier, MD	Winthrop University
Principal Investigator:	Donald V Belsito, MD	American Dermatology Associates
Principal Investigator:	Jerri Hoskyn, MD	Rivery City Dermatology
Principal Investigator:	Sandy Skotnicki-Grant, MD	Bay Dermatology Centre

More Information

Responsible Party:	Allerderm ( Kim M. Sullivan/ Study Coordinator )
Study ID Numbers:	Mekos 07 7P3.2 301, BB-IND#: 13546, Eudra CT#: 2008-000168-18, WIRB Pr. No.: 20080089
Study First Received:	March 3, 2008
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00640614
Health Authority:	United States: Food and Drug Administration; Denmark: Danish Dataprotection Agency; Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by Allerderm:

Dermatitis, Contact

Study placed in the following topic categories:

Hydrocortisone
Skin Diseases
Cortisol succinate
Parthenolide
Sodium thiosulfate
Bacitracin
Dermatitis, Contact

Gold Sodium Thiosulfate
Hydrocortisone-17-butyrate
Povidone
Skin Diseases, Eczematous
Hydrocortisone acetate
Dermatitis

Additional relevant MeSH terms:

Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions
Anti-Bacterial Agents

Therapeutic Uses
Antitubercular Agents
Chelating Agents
Antirheumatic Agents
Dermatologic Agents
Antidotes

ClinicalTrials.gov processed this record on January 14, 2009