Official Title: “Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique”

The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

Study Type: Interventional

Study Design: Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Study Primary Completion Date: June 2009

The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation. The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.

Five (5) adult subjects without a history of penicillin allergy and fifteen (15) adult subjects with a history of penicillin allergy and previous positive penicillin skin test to the minor determinant (penicilloate) and/or major determinant (penicilloyl) will be enrolled into the study. Each subject will be skin tested with our current penicillin skin test which includes penicilloate conducted in the Division of Allergic Diseases will be compared the skin test of our penicilloate prepared by our newer method along with the different diastereoisomers of penicilloic acid on the same day and time. The adult subjects without a history of penicillin allergy will serve as our control.

Intervention(s) in this Clinical Trial

• Other: penicillin skin test
  • Prick skin tests will be performed on the volar surface of the forearm with each penicilloate and control reagents. The skin test sites will be examined at 15 minutes. A positive test result is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. Patients with negative prick test results to penicillin will undergo intradermal testing. Intradermal skin tests will be performed on the volar surface of the forearm. The test reagents will be injected intradermally to produce an initial wheal of 2x2 mm. The skin test sites will be examined at 15 minutes. A positive intradermal test is defined as a wheal of 3x3 mm or greater with a surrounding zone of erythema. In order to ensure patient safety, we will consider using an end point titration technique.

Arms, Groups and Cohorts in this Clinical Trial

• No Intervention: 1
  • Patients will have the skin test placed

Primary Measures

• The primary objective of the study is to evaluate the equivalency of the skin test reactivity to penicilloate prepared by our new method of penicilloate preparation versus our old method of penicilloate preparation.
  • Time Frame: immediate
    Safety Issue?: No

Secondary Measures

• The secondary objective of the study is to evaluate the significance of the different diastereoisomers of penicilloate on skin test reactivity.
  • Time Frame: immediate
    Safety Issue?: No

Inclusion Criteria:

• 1. History of penicillin allergy
• 2. Previous or current positive skin test to penicilloate
• 3. Greater than or equal to 18 years of age

Exclusion Criteria:

• 1. Uncontrolled asthma by symptoms
• 2. Patients who have received penicillin and had no adverse drug reaction
• 3. Previous adverse reaction to penicillin skin test
• 4. Dermatological conditions that may interfere with skin testing i.e. atopic dermatitis and dermatographism
• 5. Medication that may interfere with skin testing i.e. antidepressants, antihistamines, and sedatives.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Overall Contact: Miguel Park, M.D. 507-284-1903 park.miguel@mayo.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00589251

Study ID Number: 301-06

ClinicalTrials.gov Identifier: NCT00589251

Health Authority: United States: Institutional Review Board

Mayo Clinic Clinical Trials