Who is sponsoring NCT02160587?

NCT02160587 is sponsored by Zurex Pharma, Inc..

What condition does NCT02160587 study?

NCT02160587 studies Surgical Site Infection.

What drugs are being tested in NCT02160587?

Interventions: Chloraprep, 0.9% Physiological Saline, ZuraPrep without IPA.

What is the status of NCT02160587?

NCT02160587 is currently COMPLETED.

Last reviewed 2015-03-11 · How we verify

A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers

NCT02160587 Phase 1 COMPLETED

This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.

Details

Lead sponsor	Zurex Pharma, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	208
Start date	2014-07
Completion	2014-10

Conditions

Surgical Site Infection

Interventions

Chloraprep
0.9% Physiological Saline
ZuraPrep without IPA

Primary outcomes

Skin sites evaluated and graded for irritancy or sensitization — 0-40 days post dose
Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.

Countries

United States