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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT00478751
Eligibility Criteria:
Inclusion Criteria:
For inclusion, the subject must:
1. Be at least 18 years old;
2. Be a healthy volunteer with Fitzpatrick Skin phototypes IV-VI based on the scale below:
* Burns minimally, tans easily, and above average with each exposure
* Rarely burns, tans easily and substantially
* Never burns and tans profusely
3. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs and photoprotection;
4. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form;
5. Agree to follow and undergo all study-related procedures.
Exclusion Criteria:
Subjects will be excluded if any of the following apply:
1. Women who are lactating, pregnant, or planning to become pregnant.
2. Patients with a recent history of vitiligo, melasma, and other disorders of pigmentation with the exception of post inflammatory hyperpigmentation.
3. Patients with a known history of photosensitivity disorders.
4. Photosensitizing medications may be continued throughout of the study at the discretion of the investigator (appendix A).
5. Patients with a known history of melanoma or non-melanoma skin cancers
6. Concomitant use of tanning beds.
7. Sun exposure of the irradiated or control areas.
8. Any reason the investigator feels the patient should not participate in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00478751
Study Brief:
Protocol Section:
NCT00478751