Recruiting soon

Kytogen Defend for Facial Skin Quality Improvement

What is being tested

KIO021

Device

Who is being recruted

Over 18 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorSinclair Pharmaceuticals Limited

Study ContactMD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to test the effectiveness and safety of an injectable solution called KIO021, which contains carboxymethyl chitosan. The goal is to see if this treatment can temporarily improve the condition of facial skin, specifically targeting people with dry skin and a dull complexion. Improving facial skin quality is important as it can enhance self-esteem and overall appearance. This study could potentially offer a new treatment option for individuals seeking to improve their skin condition. Participants in the study will receive injections of the KIO021 solution to assess its impact on their facial skin. The effectiveness of the treatment will be evaluated by comparing the skin condition of those who receive the injections with those who do not, through a controlled and unbiased assessment. The study does not mention specific risks, but as with any injectable treatment, there may be common side effects like redness or swelling at the injection site. This research will help verify whether KIO021 is a safe and effective option for improving facial skin quality.

Official TitleA Prospective, Multicenter, Randomized, No-Treatment-Controlled, Assessor-Blinded, Superiority Clinical Investigation to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement

NCT07179198

Principal SponsorSinclair Pharmaceuticals Limited

Study ContactMD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate

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;

1 exclusion criteria prevent from participating

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 exposed to strong sunlight or ultraviolet rays during the study period; (5) Having tattoos, piercings, significant facial hair, scars, deformities, unhealed wounds, active skin diseases or inflammation or infections (e.g., herpes, acne, eczema, dermatitis, psoriasis, herpes zoster, mycosis and papillomas, etc.), abscess, granuloma, active or persistent perinasal infection, cancers or precancerous lesions, malignant tumours or skin swellings with unknown nature, unknown injections, and facial subcutaneous fixations (mesh, thread, gold twisted wire), etc. in the injection and evaluation area that may affect the effectiveness evaluation or increase treatment-related risks; (6) Subjects who are considered not suitable for participating in this clinical trial according to evaluation of investigators.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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Recruiting soonNo study centers