BC-101 in Treatment of Nasolabial Fold Wrinkles

Launched by BRIGHT CELL, INC. · Dec 4, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called BC-101 for people who have noticeable wrinkles around their mouth, known as nasolabial folds. The study aims to test the safety and tolerability of BC-101 when injected under the skin. It is designed for adults who are in good health and have moderate to very deep wrinkles that they are unhappy with. To participate, individuals must be willing to follow the study rules and provide informed consent, meaning they understand what the study involves.

The trial is not yet recruiting participants, but it's important to know that there are certain conditions that would disqualify someone from joining. For example, individuals with skin infections, certain types of tumors, or those who have recently had cosmetic treatments in the area of the wrinkles will not be eligible. Participants will be monitored to ensure their safety throughout the study, and this could be a good opportunity for those looking to improve the appearance of their nasolabial folds.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who are in general good health condition.
• • 2. Subjects who have moderate to extremely deep bilateral nasolabial fold wrinkles, as documented by a score of 3 or greater on the six-point Evaluator Wrinkle Severity Assessment scale (0-5).
• • 3. Subjects who are dissatisfied with both nasolabial fold wrinkles based on a score of -1 or -2 on the Subject Wrinkle Assessment Scale (-2 to +2).
• • 4. Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.
• • 5. Subjects who fully understand the research nature of this study and sign the informed consent.
• Exclusion Criteria:
• • 1. Subjects who have an active cutaneous infection on the face.
• • 2. Subjects with existing malignant neoplasm.
• • 3. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).
• • 4. Subjects who have active dermal diseases, inflammation, or any related disease.
• • 5. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).
• • 6. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
• • 7. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.