Skip to main content
. 2024 May 17;18(3):357–371. doi: 10.4162/nrp.2024.18.3.357

Table 2. Criteria for inclusion and exclusion when recruiting subjects.

Criteria Terms
Inclusion criteria • Healthy female aged 35–60 yrs
• Diagnosed by dermatologists with wrinkle(s) in the Crow’s-feet area, with global photo-damage score between 2 and 6
• Subjects who calculate with Corneometer reading of less than 60 A.U.
• Informed of the purpose and the protocol of the study and signed a written informed-consent form
• Co-operative and available during the study period
Exclusion criteria • History of allergies to cosmetics, pharmaceutical products, or foods containing ingredients included in the test formulation
• Diagnosis of any systemic illness that may be aggravated by participation in the study
• Use of oral retinoids or oral steroids in the 6 mon prior to initiation of the study
• Use of topical retinoids, anti-wrinkle cosmetic products including retinol and/or AHA, or moisture-rich cosmetic products within the 6 mon prior to initiation of the study
• Skincare therapy using lasers or peeling within the 6 mon prior to initiation of the study
• Current participation in another clinical test, or participation in any type of wrinkle study within the 6 mon prior to initiation of the study
• Abnormal liver function or abnormal renal function
• Current smoking habit or history of smoking within the past 1 yr
• Excessive alcohol intake
• Women who had undergone, or planned to undergo, pregnancy or breastfeeding
• Blood pressure > 140/90 mmHg or hypertension with intake of a diuretic
• Problems with overall findings in blood-test results as determined by a specialist
• History of asthma or allergic disease
• History of depression, schizophrenia, alcoholism, drug addiction, or mental illness
• Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants
• Any condition judged by the investigator to be unsuitable for participation in the study

A.U., arbitrary units; AHA, alpha hydroxy acid.