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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03144193
Eligibility Criteria:
Inclusion Criteria:
* Have moderate to severe photoaging of facial skin (grade 6 or above on the Griffiths scale);
* Willing to submit to examination of facial skin, hands and forearms;
* Willing to submit to self-treatment with product or placebo cream on face, hands and forearms, including wrists and extensor forearms, for 6 months;
* Willing to submit to clinical photography;
* Willing to submit to 3 mm punch biopsies from the wrist at beginning and end of trial;
* Signed informed consent.
Exclusion Criteria:
* Skin disease that would impair evaluation of the test sites;
* Topical or systemic retinoid within the past 6 months and 12 months respectively prior to entry to the study;
* Topical steroid or other topical drugs at treatment sites for at least two weeks prior to study entry;
* History of use of experimental drug or experimental device in the 30 days prior to entry into the study;
* Any significant cosmetic treatment for skin rejuvenation i.e. dermabrasion, chemical peels, face-lifts;
* Known allergy to any of the product or placebo ingredients;
* History of keloid scars.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT03144193
Study Brief:
Protocol Section:
NCT03144193