HRIPT Study to Evaluate the Irritation and Allergenic Potential of Medical-grade Norway Spruce (Picea Abies) Resin Salve (Abilar)

Exclusion Criteria

• •Pregnancy or lactation.
• •Inadequate or non-existent contraception (women of child bearing potential only).
• •A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis).
• •Heavy alcohol consumption (i.e. more than 21 units per week or 8 units a day for men, more than 14 units per week or 4 units a day for women).
• •Current use or history of repeated use of street drugs.
• •A febrile illness lasting more than 24 hours in the six days prior to first patch application.
• •Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
• •History of asthma only if requiring regular medication or hay fever that required prescription treatment in two or more of the previous three years.
• •A history of multiple drug hypersensitivity.
• •Concurrent medication likely to affect the response to the test articles or confuse the results of the study.
• •Known sensitivity to the test articles or their constituents including patch materials.
• •Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
• •Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
• •Sensitisation or questionable sensitisation in a RIPT.
• •Recent immunisation (less than 10 days prior to test patch application).
• •A medical history indicating atopy.
• •Prohibitions and Restrictions:
• •No use of aspirin or non-steroidal anti-inflammatory drugs for the duration of the study.
• •No use of sun beds or sun lamps and no deliberate exposure of the test sites to natural sunlight for the duration of the study.
• •No immunisation from ten days prior to first patching until study completion.