Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars

• 1. Participants with hypertrophic scars aged ≥18 years and \<65 years at randomization, with no restriction on sex.

  2. Subjects experienced burn, surgery, trauma or other events within 6 months prior to screening; the wound has healed and scar formation (linear or extensively growing hypertrophic scar) confirmed by investigator assessment.

  3. The target treatment scar selected upon investigator judgment meets the morphological characteristics of hypertrophic scar: the scar rises above normal skin tissue, confined within the lesion area, and the subject reports no obvious spontaneous scar regression recently.

  4. The modified Vancouver Scar Scale (mVSS) score of the target scar is between 7 and 15, inclusive.

Exclusion Criteria:

• 1. The target scar is located on the head and face, both hands, genitals, or areas with severely limited joint movement.

  2. Subjects who received systemic or intralesional corticosteroids (triamcinolone acetonide, betamethasone, etc.), immunosuppressants, chemotherapeutic agents (5-fluorouracil, bleomycin, mitomycin C, etc.), biological products (botulinum toxin, hyaluronidase, interferon, etc.) for scar treatment within 2 months prior to dosing.

  3. Subjects who received scar treatments including laser, radiotherapy, cryotherapy, compression therapy within 2 months prior to dosing.

  4. Subjects with local infection on the hypertrophic target scar at screening, or with systemic infection.

  5. Subjects diagnosed with keloid, atrophic scar or scar carcinoma. 6. Subjects with previous or current clinically significant diseases including but not limited to diseases of digestive, cardiovascular, respiratory, urinary, musculoskeletal, endocrine, immune, neuropsychiatric, hematological systems, or history of malignant tumors, who are judged by the investigator to be unsuitable for enrollment.

  1. Subjects with syphilis (positive treponema pallidum antibody), AIDS (positive HIV antibody), active hepatitis C (positive HCV antibody), or active hepatitis B (positive HBsAg). Non-active HBsAg carriers and hepatitis B patients treated with stable condition (HBV DNA \< 500 IU/mL) are eligible for enrollment; HBV DNA will be monitored periodically per investigator's recommendation during the study. Subjects with positive HCV-Ab may be enrolled if HCV RNA is negative, and HCV RNA will be monitored periodically per investigator's recommendation during the study.
  2. Uncontrolled hypertension within 1 month prior to screening (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg in sitting position despite optimal antihypertensive therapy).
  3. Any of the following laboratory abnormalities at screening: ALT or AST > 3 × ULN; total serum bilirubin > 1.5 × ULN; serum creatinine > 1.5 × ULN; creatinine clearance \< 60 mL/min; hemoglobin (Hb) \< 80 g/L; platelet (PLT) \<75.0 ×10⁹/L; fasting plasma glucose (FPG) ≥7.0 mmol/L (126 mg/dL); HbA1c ≥6.5%.