BC-101 in Treatment of Nasolabial Fold Wrinkles

Bright Cell

Status and phase: Begins enrollment in 9 months; Phase 1

Conditions: Nasolabial Fold Wrinkles

Treatments: Biological: BC-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05162326

BC101-C01

Details and patient eligibility

About

This is an open-label, single-arm, dose-escalating study to evaluate the safety and tolerability of BC-101 administered via subcutaneous/intradermal injection in the treatment of moderate to severe nasolabial folds.

Enrollment: 9 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 1 patient group

BC-101

Experimental group

Description:

BC-101 will be injected at the dose of 0.1 mL per linear centimeter along the nasolabial fold, up to 2 mL in total volume for each side of the nasolabial folds.

Treatment:

Biological: BC-101