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BC-101 in Treatment of Nasolabial Fold Wrinkles | Clinical Trials | Clareo Health

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Not Yet RecruitingPhase 1NCT05162326

BC-101 in Treatment of Nasolabial Fold Wrinkles

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 na...

Lead sponsor: Bright Cell, Inc.•View source on ClinicalTrials.gov

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Contacts

Jennifer Wang

CONTACT

949-333-3636 jenniferw@brightcellinc.com

Sponsors

Lead Sponsor

Bright Cell, Inc.

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 29, 2025Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhasePHASE1

Enrollment9

Start dateDec 2026

Last updatedDec 29, 2025

Condition

Nasolabial Fold Wrinkles

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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: May 10, 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.

View ClinicalTrials.gov Terms and Conditions