BC-101 in Treatment of Nasolabial Fold Wrinkles
- Conditions
- Nasolabial Fold Wrinkles
- Registration Number
- NCT05162326
- Lead Sponsor
- Bright Cell, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria:<br><br> 1. Subjects who are in general good health condition.<br><br> 2. Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as<br> documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity<br> Assessment scale (0-5).<br><br> 3. Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of<br> -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2).<br><br> 4. Subjects who voluntarily adhere to the research procedures and ensure good<br> compliance during the research period.<br><br> 5. Subjects who fully understand the research nature of this study and sign the<br> informed consent.<br><br>Exclusion Criteria:<br><br> 1. Subjects who have an active cutaneous infection on the face.<br><br> 2. Subjects with existing malignant neoplasm.<br><br> 3. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).<br><br> 4. Subjects who have active dermal diseases, inflammation, or any related disease.<br><br> 5. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months<br> before the study (including laser, chemical peels, fillers, botulinum toxin).<br><br> 6. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is<br> positive before participation in the study.<br><br> 7. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of any treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method Changes in wrinkle severity assessment from baseline