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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT06654102
Eligibility Criteria:
Inclusion Criteria:
* Uniform skin color over the whole test area (the lower back) with minimal variation between test sites.
* At least 3 subjects per skin type, as defined by self-reported reaction to sun exposure and Chromameter measurements.
* Generally in good health.
* Able to read, write, speak, and understand English.
* Intends to complete the study and is willing and able to follow the subject responsibilities.
Exclusion Criteria:
* In another study without approval by the study site.
* Has known allergies or negative reactions to common topical skincare products or UV light.
* Has a history of abnormal responses to sunlight or UV radiation.
* Has used a tanning bed/lamp, has had extended sun exposure of the test area, or has participated in a UV exposure study within the past 4 weeks.
* Has a current illness/condition/situation, a medical history of a disease/condition, or a skin condition (e.g., psoriasis, rashes, eczema, seborrheic, severe excoriations, etc.) that could confuse the study results, interfere with participation, or increase health risk to the subject, as determined by the study investigator.
* Has shaved/waxed the test area within 2 weeks before Visit 1.
* Has used any products in the test area within 24 hours before Visit 1.
* Has sunburn, suntan, scars, tattoos, active dermal lesions, nevi, or other conditions in the test area that could confuse the study results or increase health risk to the subject, as determined by the study investigator.
* Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
* Is immunosuppressed (such as HIV-positive, transplant patients, undergoing chemotherapy or radiotherapy, etc.).
* Has been using a product or medication that the study investigator determines will increase health risk to the subject or confuse the study results
* Has a personal or family history of skin cancer.
* Skeletal protrusions and/or extreme areas of curvature in the test area.
* Is pregnant, nursing, or planning to become pregnant.
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06654102
Study Brief:
Protocol Section:
NCT06654102