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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07335003
Eligibility Criteria:
Inclusion Criteria:
1. Adult outpatients ≥ 60y old with at least 11 clinically typical actinic keratosis lesions, including at least one on the face;
2. Patient having understood and signed a written informed Consent Form to participate in the study indicating the potential participant's willingness to undergo the study procedures and complete the study.
Exclusion Criteria:
1. Atypical actinic keratosis lesions including suspected squamous cell carcinoma and basal cell carcinoma (could be present at screening and treated but cannot be present at 1st visit);
2. History of \>2 squamous cell carcinomas;
3. Known history of immunodepression whatever its cause in the past year;
4. Participants who cannot undergo skin biopsies, with a history of scarring problems or who have developed adverse effects from the use of local anesthesia will also be excluded.
5. Participant using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressive drugs, corticosteroids, retinoids, other keratolytics or have received investigational drug within 4 weeks before enrolment
6. Participant having active, localized or systemic infection other than the AK lesions
7. Participant having any dermatological affection within the treated and adjacent area according to the Investigator judgement
8. Participant having a present or past skin condition that according to Investigator judgment, deems inappropriate for study participation
9. Participant having other significant medical conditions that according to Investigator Judgment, deems inappropriate for study participation
10. Participant having a known hypersensitivity, allergy or contraindication to any ingredients contained within the cosmetic products,
11. Participant taking part or intending to take part in another study for 30 days prior to D1 visit, and 30 days following last study visit. that according to Investigator judgment, deems inappropriate or may interfere for study participation
12. Participant using light-based devices such as but not limited to PUVA (Psoralen Ultraviolet A therapy), IPL (Intense Pulsed Light), laser, LED (Light Emitting Diode) devices or tanning beds, within 4 weeks before enrolment.
13. Participant having applied any topical product on the investigational areas the day of enrolment visit,
14. Participant under legal guardianship or incapacitation.
15. Participant being psychologically incapable of signing informed Consent Form and unable to comply with the protocol requirements according to investigator judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07335003
Study Brief:
Protocol Section:
NCT07335003