A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study to Evaluate the Efficacy and Safety of TF0023 Spray Versus Placebo in Functional Improvement of Patients With Ischemic Strokes

• Male or female 18 to 85 years of age at the time of signing the informed consent form.

• Patient or patient's legal representative must understand and voluntarily sign the informed consent form prior to any study-related assessments/procedures are conducted.

• Able to adhere to the study visit schedule and other protocol requirements.

• A female of childbearing potential must have a negative serum at screening and negative urine pregnancy test prior to treatment with study therapy. In addition, sexually active females of childbearing potential must agree to use two of the following adequate forms of contraception methods simultaneously: oral, injectable or implantable hormonal contraception; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner for the duration of the study and the follow-up period. Males, including those who have had a vasectomy, must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with a female of childbearing potential for the duration of study and follow-up period.

• Must have a diagnosis of ischemic stroke and be stable enough to be randomized to treatment within 3 to 60 days after the onset of stroke symptoms. The stroke event needs to involve the middle cerebral artery (MCA) territory (cortical or subcortical) or posterior cerebral artery (PCA) territory with ischemic stroke confirmed by magnetic resonance imaging (MRI). Ischemic stroke is defined as death of an area of brain tissue (cerebral infarction) resulting from an inadequate supply of blood and oxygen to the brain.

• National Institute of Health Stroke Scale (NIHSS) score ≥3 but \<22 at the time of screening, at least 3 days after the onset of stroke symptoms. Patient should not have shown rapid improvement (≥8 point decrease since the onset of stroke symptoms) or deterioration (≥4 point increase since the beginning of screening) in the NIHSS score from time of initial evaluation to randomization. The time from initial evaluation to initial screening evaluation will be at least 72 hours.

• New onset of extremity paresis on the affected side, defined as a score of 2 to 4 on the NIHSS Motor Arm (item 5) or Leg (item 6) question.

• Must be alert or drowsy but easily arousable as defined by a score of 0 to 1 on the NIHSS Level of Consciousness question (item 1).

• Slow recovery defined as change in NIHSS ≤1 point/3 days during the screening period.

⁃ Able to participate in the evaluation process to the point of accurate assessment with/without help.

⁃ Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures.

⁃ Must be willing to discontinue applying any topical preparations containing Vitamin A acids (including all-trans-retinoic acid \[tretinoin\], 13-cis-retinoic acid \[isotretinoin\], 9 cisretinoic acid \[alitretinoin\], vitamin A \[retinol\], retinal, and their derivatives) to any part of the body starting on Day 1 until study completion. (TF0023 may cause dry and/or itching skin. Curél Ultra Healing Lotion can be applied to the dry and/or itching skin).