Proof of Concept Anti-ageing Clinical Study in Healthy Subjects (NCT03180645) | Clinical Trial Compass
CompletedNot Applicable
Proof of Concept Anti-ageing Clinical Study in Healthy Subjects
Germany72 participantsStarted 2017-03-20
Plain-language summary
The objective of this POC clinical study is to evaluate the moisturising effects on fine lines and wrinkles, texture, barrier function, hydration and elasticity delivered by 4 weeks of twice daily application of the test product on participants presenting visible signs of ageing.
Who can participate
Age range30 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
* Good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant and relevant abnormalities in medical history or upon physical examination
* Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception. Adequate contraception is defined as abstinence, oral contraceptive, either combined or progestogen alone OR injectable progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR percutaneous contraceptive patches OR intrauterine device or intrauterine system OR double barrier method (condom or occlusive cap \[diaphragm or cervical vault caps\] plus spermicidal agent \[foam, gel, film, cream, suppository\]) OR male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that participant
* Willingness to actively participate in the study and to attend all scheduled visits
* Fitzpatrick phototype I-IV
* Visual Clinical Fitzpatrick Wrinkle Score 3- 6 in the eye (crow's feet) area on both sides of the face at screening and baseline
* Subjects with self-reported sensitive skin
Exclusion Criteria:
* Women who are known to be pregnant or who are in…
What they're measuring
1
Change From Baseline in Ra (a dermaTOP Parameter), of Test Product Treated Versus (vs.) Untreated Side at Day 29