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:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01105234
Eligibility Criteria:
Inclusion Criteria:
* Subjects having understood and signed an informed consent form.
* Either sex
* Healthy subjects, 18 to 65 years of age
* Subjects with skin types I to IV according to Fitzpatrick Scale
* Subjects without erythema on test areas on the mid back skin (visual irritation score = 0) at baseline (Day 1), before randomisation.
Exclusion Criteria:
* Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
* Any topical or systemic corticosteroids or immuno-suppressors within 3 weeks prior to randomisation
* Any other medication which may interfere with the study results, in particular topical drugs applied on the test area within 2 weeks prior to randomisation
* Any other products which may interfere with the study results, in particular emollients, creams, gels, lotions and body powders applied on the test area within 24 hours prior to randomisation
* Any systemic or cutaneous disease that may confound interpretation of the study results (e.g., atopic dermatitis, eczema, psoriasis)
* Scars, moles, sunburn, or other blemishes in the test area which may interfere with grading
* Exposure to excessive or chronic UV radiation (i.e., sunbathing, solarium, phototherapy) within 2 weeks prior to randomisation or is planned during the study period
* Known or suspected hypersensitivity to any component of the investigational products
* Participation in any other interventional clinical trial within 4 weeks prior to randomisation or during the study period, based on interview of the subject
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01105234
Study Brief:
Protocol Section:
NCT01105234