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BC-101 in Treatment of Nasolabial Fold Wrinkles

A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection

NCT05162326•Bright Cell, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

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.

Key Dates

Start Date

December 1, 2026

Primary Completion Date

December 30, 2027

Completion Date

February 20, 2028

Last Updated

December 29, 2025

Enrollment

ESTIMATED participants

Conditions

Nasolabial Fold Wrinkles

Interventions

BC-101

BIOLOGICAL

Contacts

Jennifer Wang

CONTACT

949-333-3636 jenniferw@brightcellinc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BC-101 in Treatment of Nasolabial Fold Wrinkles

Inclusion Criteria

Exclusion Criteria

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