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:
NCT03508856
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be adults aged 45-75 years of age.
* Subjects must be in good general health as confirmed by the medical history.
* Subjects must be able to read, sign, and understand the informed consent.
* Subjects must meet the criteris for Glogau Photoaging class III or class IV.
* Subjects have a diagnosis of actinic keratosis.
* Subjects must be willing to apply Picato 0.015% gel
* Subjects must be willing to forego any other treatments on the face, including cosmetic treatments, tanning bed use, and excessive sun exposure while enrolled in the study.
* If a subject is a female of childbearing potential she must have a urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
Exclusion Criteria:
-. Subjects with a history of melanoma anywhere on the body.
* Subjects with any unstable medical condition as determined by the clinical investigator.
* Subjects with untreated non-melanoma skin cancer on the face or within the treatment area.
* Subjects with dermatitis or any dermatologic disease in the treatment area that would obscure the evaluation of photoaging parameters.
* Subjects who have undergone any form of 'field treatment' including 5-fluorouracil, photodynamic therapy, or ingenol mebutate in the preceeding six months.
* Women who are pregnant, lactating, or planning to become pregnant during the study period.
* Subjects who have experienced a major medical event (including stroke, heart attack, etc) within 90 days of starting the study.
* Subjects who have active substance abuse disorders.
* Subjects who have known allergies to any components of the study drug.
* Subjects who are currently particpating in another clinical trial or who have completed a study involving laser, systemic, or topical treatment of the face within 30 days prior to study treatment initiation.
* Subjects who have received any of the following within 90 days prior to study treatment initiation:
* Interferon or interferon inducers
* Cytotoxic drugs
* Immunomodulators or immunosuppressive treatments (except inhaled or intranasal corticosteroids)
* Oral or parenteral corticosteroids
* Topical steroids to treatment area
* Any dermatologic procedures or surgeries to the treatment area, including cryosurgery for AKs
* Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT03508856
Study Brief:
Protocol Section:
NCT03508856