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Study aim
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Evaluation of the Safety and Effectiveness of Inovo Sense Smile and Inovo Sense Style Intradermal Injectable Gel for Correcting Moderate to Severe Nasolabial Folds
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Design
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An interventional, randomized, non-blinded, non-placebo, single-study, treatment-intent, phase 2 clinical trial on 30 patients.
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Settings and conduct
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The study will be conducted in the dermatology clinic of Razi Hospital. Before the intervention, face photography will be taken from participants using a Visioface camera، and the intensity of the wrinkles is scored based on the 5-point photonumeric Allergan scale from 0 (no wrinkles) to 4 (very deep wrinkles). For each person with a score of 3, one injection with 1 ml of Inovo Sense Smile gel, and for each person with a score of 4, one injection with 1 ml of Inovo Sense Style gel (produced by Khosro Medisa Teb) intradermally in the NLF will be done. The assessments will be repeated immediately after the intervention, 2 weeks and 3 months later. Subjects’ satisfaction and adverse effect will be recorded in each follow-up visit.
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Participants/Inclusion and exclusion criteria
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30 -65 years old women and men, with moderate to severe nasolabial folds, without any cosmetic facial procedures during the last 3 months, without any allergy to lidocaine, hyaluronic acid and no autoimmune or immune deficiency diseases. No pregnant and breastfeeding
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Intervention groups
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Injection of Inovo Sense Smile and Inovo Sense Style Intradermal gel in the nasolabial folds, the products are in the
1 ml prefilled sterilized syringe containing:
Inovo Sense Smile:
Hyaluronic Acid gel 20 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 ml
Inovo Sense Style:
Hyaluronic Acid gel, 23 mg; Lidocaine hydrochloride, 0.3% ; Phosphate buffer (pH 7), 1 ml
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Main outcome variables
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Severity of nasolabial folds based on the 5-point photonumeric Allergan scale