A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improve… (NCT07179198) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants
500 participantsStarted 2025-09-22
Plain-language summary
This study was designed to evaluate the efficacy and safety of KIO021, an injectable solution for carboxymethyl chitosan, for temporary improvement of facial skin condition. Designed for forward-looking effectiveness.
To achieve this, it is planned that 500 subjects with dry skin and dull complexion on the face will be included in the injection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* (1) Subjects ≥18 years (subject to the time of signing the ICF), without any restriction on gender; (2) Skin types ranging from type II to IV according to Fitzpatrick classification; (3) The subject exhibits symptoms of dry skin and dull complexion on face, and has a temporary need to improve the quality of facial skin. After evaluation by the investigator, it is deemed suitable for improvement through the medical device used in this trial;
Exclusion Criteria:
* (1) Subjects who have known allergies to Carboxymethyl Chitosan Solutions or any ingredients contained in the product; have known allergies to any local anesthetics (e.g., lidocaine or other amide-type anesthetics) or to an excipient of 5% EMLA cream; are allergic to chlorhexidine (or similar products) or to an excipient found in 0.5% alcohol chlorhexidine; or have a history of severe allergies or any episodes of anaphylactic shock; (2) Subjects having participated in other clinical trials within 1 month prior to enrollment in this trial or being currently participating in other clinical trials; (3) Females who are pregnant, breastfeeding, or planning to become pregnant during the study, or those who have been menopausal for less than 1 year or are in the perimenopausal phase without undergoing hormone therapy; (4) Subjects who have been exposed to strong sunlight or strong ultraviolet rays within 1 month before screening, or who are expected to work outdoors for a long time or need to be expo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The global aesthetic improvement scale and facial skin dryness and dull complexion comprehensively improvement
Timeframe: From enrollment to the end of treatment at 3 months