Treatment Dosage and Mode of Administration Sample Clauses

Treatment Dosage and Mode of Administration. ‌ The injection technique (skin disinfection material, type of syringe, type and gauge of the intradermal needle, penetration angle, depth) will be the technique customarily used by the Investigator. The type of gauge of the injection needle will be recorded in the CRFs. PLLA: two treatment sessions at 4-week interval with the first treatment at Visit 1 and the second treatment at Visit 3. Each treatment session will be consisted of multiple deep dermal injections, up to 9 mL/session (or up to 4.5 mL/NLF/session), into the left and right NLFs of each subject according to the IFU. The treatment amount for each PLLA subject will be determined at the Investigator discretion to achieve an optimal correction. Within each PLLA subject, the amount of each treatment needs to be equal at the left and right NLFs because of the identical WAS scores. The treatment volume injected during each treatment session for each subject will be recorded in the CRFs. CaHA: up to two treatment sessions at 4-week interval with the required first treatment at Visit 1 and an optional second treatment at Visit 3 to achieve an optimal cosmetic correction. Each treatment session will be consisted of multiple subdermal injections, up to 1.5 mL/session (or up to 0.75 mL/NLF/session), into the left and right NLFs of each subject according to the IFU. The second treatment is optional and will be determined based on the Investigator assessment. If the subject needs a second treatment, an appropriate amount will be determined at the Investigator discretion to achieve an optimal outcome. The amount of each treatment needs to be equal at the left and right NLFs because of the identical WAS scores. The treatment volume injected during each treatment session for each subject will be recorded in the CRFs.
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