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A multicenter prospective study on the efficacy and safety of VYC-12L

A multicenter prospective study on the efficacy and safety of VYC-12L - A multicenter prospective study on the efficacy and safety of VYC-12L

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000057791
Enrollment
100
Registered
2025-05-07
Start date
2025-08-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surface depressions such as fine wrinkles on the face and neck

Interventions

None listed

Sponsors

Imaizumi Skin Clinic
Lead Sponsor
Chiharu skin clinic, Akihabara Skin clinic, Prima clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Individuals aged 18 years or older who are outpatients (gender is not restricted). 2)Those who wish to improve skin quality for their cheeks and have reported concerns about dryness (a dryness level of 1 or higher) in the questionnaire form. 3)Those who can comply with the outpatient visits according to the study schedule. 4)Those who have received a sufficient explanation about participating in this study, fully understood it, and provided written consent of their own free will.

Exclusion criteria

Exclusion criteria: 1)Individuals who have undergone ECM therapy, chemical peels, EBD therapy, or dermal filler injections within 6 months of obtaining consent. 2)Individuals with a history of treatments for the target area that provide permanent or semi-permanent effects (improvements). 3)Individuals with a history of allergies or hypersensitivity to hyaluronic acid. 4)Individuals with skin lesions in the target treatment area. 5)Individuals with a history of anaphylaxis or those prone to allergic reactions such as urticaria. 6)Individuals with a history of streptococcal diseases (e.g., recurrent pharyngitis, acute rheumatic fever) or those with acute rheumatic fever accompanied by cardiac complications. 7)Individuals with abnormal immune function or a history of such conditions, or those receiving immunosuppressive therapy. 8)Individuals prone to keloid formation, hypertrophic scars, or pigmentation disorders. 9)Individuals with bleeding tendencies or those using anticoagulants such as aspirin, NSAIDs, or warfarin. 10)Individuals who have undergone or are scheduled to undergo treatments such as laser therapy, chemical peels, or other dermabrasion methods. 11)Individuals with cardiac conduction disorders. 12)Individuals with severe liver or kidney dysfunction. 13)Individuals with porphyria. 14)Individuals who are pregnant, suspected to be pregnant, or breastfeeding. 15)Others deemed unsuitable for participation in this study by the principal investigator or co-investigator.

Design outcomes

Primary

MeasureTime frame
the physician's GAIS assessment at 4 weeks after the start of treatment, compared to week 0 (baseline)

Secondary

MeasureTime frame
GAIS assessment by physicians at 8, 16, and 24 weeks after treatment initiation, compared to the baseline. GAIS assessment by study participants at 4, 8, 16, and 24 weeks after treatment initiation, compared to the baseline. Changes in the FACE-Q Skin Scale at 4, 8, 16, and 24 weeks after treatment initiation, compared to pre-treatment values. Changes in the Psychological Scale at 4, 8, 16, and 24 weeks after treatment initiation, compared to pre-treatment values.

Countries

Japan

Contacts

Public ContactAkiko ImaizImaizumi

Imaizumi Skin Clinic N/A

akitoshi2400@gmail.com0120-006-762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026