CompletedNot Applicable

Efficacy and Safety Study of SkinPlus-Hyal® to Nasolabial Fold

South Korea123 participantsStarted 2013-07

Plain-language summary

\- Study design:Multi-center, randomized, double-masked (Unblinded treating investigators), intra-individual comparison clinical trial

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Men and women aged over 20
✓. Subjects who want to correct his/her nasolabial fold and have point 3 or 4 in WSRS of nasolabial fold and visually symmetric
✓. Subjects who voluntarily decided the participation of the study and signed the informed consent
✓. Subjects who agree contraception

✕. Subjects who had anaphylaxis or a severe combined allergy, or an allergy to hyaluronic acid
✕. Subjects who had eczema, infection, psoriasis, sclerosis, acne on the face
✕. Subjects who have a skin disorder on the NLF area
✕. Subjects who had permanent implants for dermal augmentation at the NLF area
✕. Subjects who had a history of keloid formation or hypertrophic scar
✕. Subjects who participated in other clinical trial within 3 months from screening date
✕. Female subjects of childbearing potential who disagreed with medically acceptable contraception (e.g., condom, oral contraceptives continuing at least 3 months, injectable or insertable contraceptives, intrauterine contraceptive devices) during the trial
✕. Subjects who is Drug abuser or alcoholism

The change in WSRS of the test group and control group

Timeframe: Baseline and 24 weeks

NCT IDNCT01940575

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01