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A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants | Clinical Trials | Clareo Health

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A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants

A 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•Sinclair Pharmaceuticals Limited

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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 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.

Key Dates

Start Date

September 22, 2025

Primary Completion Date

June 30, 2026

Completion Date

November 30, 2026

Last Updated

September 17, 2025

Enrollment

500

ESTIMATED participants

Conditions

Skin Quality

Interventions

KIO021

DEVICE

Contacts

CONTACT

+85219083151460 bdyyjxb@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Safety and Effectiveness of Kytogen Defend in Facial Skin Quality Improvement in Adult Participants

Inclusion Criteria

Exclusion Criteria

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