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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT02902718
Eligibility Criteria:
Inclusion Criteria:
1. Healthy female between the ages of 25 and 60.
2. Willing to sign Informed consent form and photo release form.
3. Having visible lines and wrinkles in the peri-orbital and peri-oral region of the face (Fitzpatrick elastosis degree 3-6).
4. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
5. Agree to make no changes in their existing skincare regime, other than use of the study products, during the study period.
6. If female, must be either post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence).
Exclusion Criteria:
1. Subjects who currently use or have used in the prior 30 days any skin products that contain alpha hydroxy acids (AHA) e.g. glycolic, lactic, citric, or mandelic acid containing products or retinol/tretinoin containing products or exfoliating washes, masks or scrubs or other micro-dermabrasion skin care products on the treatment areas.
2. Subjects who are unwilling to maintain their daily skin care regimen for the duration of the study.
3. Subjects who have any skin pathology or condition that could interfere with the evaluation i.e. personal or family history of skin cancer, rosacea and/or requires the use of interfering topical or systemic therapies.
4. Subjects with synthetic or metal implants or permanent cosmetic tattoos in the test areas.
5. Subjects who have a history of abnormal scarring, e.g. keloids or have significant scarring in the areas to be treated.
6. Subjects with bleeding disorders or taking anticoagulation medications, including heavy use of aspirin.
7. Subjects who have participated in any clinical investigation involving the face within the 30 days prior to the first planned treatment or subjects who plan to participate in concomitant facial studies during this trial.
8. Subjects, who are pregnant, were pregnant or gave birth in the last 3 months, are currently breast feeding, or might become pregnant during the course of the study.
9. Subjects who have a history of light triggered seizures.
10. Subjects with prior use of neurotoxins e.g. Botox®, collagen, fat injections and/ or other methods of skin augmentation (enhancement with injected or implanted material) of the face or having had chemical peels within 6 months of initial laser application or planning to so during the course of the study.
11. Subject's use of oral isotretinoin (Accutane®) within 12 months of initial device application or during the course of the study.
12. Subjects having had facial skin treatments with any professional laser, light based, radiofrequency or other devices within the last year.
13. Subjects ever having facial skin treatments with home use laser, light based or radiofrequency or other devices, i.e. PaloVia® or Tria®.
14. Subjects with facial plastic surgery within the last 12 months of the initial laser application or planning to do so during the course of the study.
15. Subjects who have had sun exposure or used a tanning bed 4 weeks prior to the start of the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT02902718
Study Brief:
Protocol Section:
NCT02902718