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

Completed · Phase 3

Conditions studied: Contact Dermatitis

In brief

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.

Key facts

Study ID

NCT00640614

Run by

Allerderm

People needed

235

Starts

2008-04-01

Expected to finish

2009-10-01

Last updated by the study team

2020-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.