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Sponsored by: |
Allerderm |
Information provided by: | Allerderm |
ClinicalTrials.gov Identifier: | NCT00640614 |
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 |
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 |
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.
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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.
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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. |
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:
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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Sensitive subjects must have a positive patch test to one of the following allergens within the past 10 years.
Exclusion Criteria:
Contact: Erin L Oliver, BA | +1 602-225-0595 ext 520 | eoliver@smarthealth.com |
Contact: Kim M Sullivan | +1 602-225-0595 ext 274 | sullivan@smarthealth.com |
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 |
Allerderm |
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 |
Responsible Party: | Allerderm ( Erin L. Oliver / Clinical Coordinator ) |
Study ID Numbers: | Mekos 07 7P3.2 301, BB-IND#: 13546, Eudra CT#: 2008-000168-18, WIRB Pr. No.: 20080089 |
First Received: | March 3, 2008 |
Last Updated: | July 2, 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 |
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