Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT06810856
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers, of either sex, aged at least 18 years.
* Completed written informed consent.
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06810856
Study Brief:
Protocol Section:
NCT06810856