評估 BB-101用於治療雷射手術後萎縮性痤瘡疤痕的療效與安全性。

外用液劑
外用液劑

重組人類新型表皮生長因子(rhNEGF)
20 mM Tris緩衝液，pH 8.0

370
370

20 µg/mL
20 mM Tris緩衝液

患者和觀察者疤痕評估量表 (POSAS)-觀察者量表（Patient and Observer Scar Assessment Scale — Observer Scale )

1.Subjects are over 18 years of age.
2.Subjects present with atrophic acne scars classified as Grade 3 or 4 (moderate to severe) on both cheeks based on the Goodman and Baron grading system.
3.Subjects did not participate in any other study in the past 6 months.
4.Subjects who understand and are able to comply with follow-up visits and treatment during the trial period.
5.Subjects who are willing and capable of providing written informed consent. Not a person subject to a sentence of guardianship or subject to judicial guardians.
6.Female subject is either:
•Not of childbearing potential: postmenopausal (defined as no spontaneous menses for at least 12 consecutive months prior to Screening), or documented to be surgically sterile or status post-hysterectomy (at least 1 month prior to Screening).
• Or, if of childbearing potential: must have a negative urine or blood pregnancy test at Screening and on Day 1 before the first dose of study drug is administered, and must use 2 acceptable methods of birth control if sexually active from Screening through 1 month after the last dose of study drug.
7.Sexually active male subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control from Screening through 3 months after the last dose of study drug.
Note. Effective contraceptive measures include condom with or without spermicide; a combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods); vasectomy; partner using stable contraceptive measures (combined [estrogen and progestogen-containing] hormonal contraception or progestogen-only hormonal contraception initiated 2 or more menstrual cycles prior to Screening, intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral tubal ligation); and/or sexual abstinence.

1.Subjects with active acne, keloids and hypertrophic scars.
2.Subjects are not allowed to use prohibited medications or therapies within two weeks before study admission and continuing until the end of the study. The decision to exclude subjects based on drug use or therapy use is determined by the investigator if it could impact the study.
3.Subjects have active infection or inflammation at the intended facial treatment area.
4.History of known serious postoperative complications.
5.Subjects who are pregnant or breastfeeding women.
6.Others who have been judged by the investigator as participating in this trial will endanger their physical and mental health.
7.Subject has inadequate marrow, hepatic, and renal function at the Screening Visit defined as:
- Platelet count < 50 x109/L (< 50,000 cells/mm3)
- Hemoglobin < 8.5 g/dL (< 5.3 mmol/L)
- Red blood cell count (RBC) < 3.0 × 10¹²/L (< 3.0 × 10⁶/μL)
- White blood cell count (WBC) < 3.0 × 10⁹/L (< 3,000 cells/μL) or > 12.0 × 10⁹/L (> 12,000 cells/μL)
- Fasting plasma glucose (FPG) ≥ 160 mg/dL (≥ 8.9 mmol/L) or ≤ 70 mg/dL (≤ 3.9 mmol/L); or, if no fasting specimen is available, random plasma glucose ≥ 200 mg/dL (≥ 11.1 mmol/L)
- Blood urea nitrogen (BUN) > 30 mg/dL (> 10.7 mmol/L)
- International normalized ratio (INR) > 1.7
- Albumin < 2.8 g/dL (< 28 g/L)
- Total Bilirubin (TBL) > 2 x ULN
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) > 5 x ULN
- Creatinine > 1.5 x ULN
Note: Transfusions/infusions to meet eligibility criteria are not allowed