BC-101 in Treatment of Nasolabial Fold Wrinkles

Phase 1

Not yet recruiting

• Conditions: Nasolabial Fold Wrinkles
• Interventions: Biological: BC-101

• Registration Number: NCT05162326
• Lead Sponsor: Bright Cell, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-04
• Study First Submitted QC: 2021-12-04
• Study First Posted: 2021-12-17
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Study Start: 2025-12-01
• Primary Completion: 2026-12-30
• Study Completion: 2027-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
BC-101	BC-101	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.

Primary Outcome Measures

Name	Time	Method
Incidence of any treatment-emergent adverse events	12 weeks after injection

Secondary Outcome Measures

Name	Time	Method
Changes in wrinkle severity assessment from baseline	6 weeks, 12 weeks and 26 weeks after injection	Each of the bilateral nasolabial fold wrinkles at rest will be evaluated using the 6-point ordinal Lemperle Wrinkle Severity Scale.