Not Yet RecruitingPhase 1

BC-101 in Treatment of Nasolabial Fold Wrinkles

9 participantsStarted 2026-12-01

Plain-language 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.

Who can participate

Age range40 Years – 80 Years

SexALL

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Inclusion criteria

✓. Subjects who are in general good health condition.
✓. 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).
✓. 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).
✓. Subjects who voluntarily adhere to the research procedures and ensure good compliance during the research period.
✓. Subjects who fully understand the research nature of this study and sign the informed consent.

Exclusion criteria

✕. Subjects who have an active cutaneous infection on the face.
✕. Subjects with existing malignant neoplasm.
✕. Subjects with persistent pre-cancerous lesions (e.g., actinic keratosis).
✕. Subjects who have active dermal diseases, inflammation, or any related disease.
✕. Subjects who have cosmetic or surgical treatment on nasolabial fold area in 3 months before the study (including laser, chemical peels, fillers, botulinum toxin).
✕. Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is positive before participation in the study.
✕. Subjects who are allergic to low-molecular-weight heparin sodium or human albumin.

What they're measuring

Incidence of any treatment-emergent adverse events

Timeframe: 12 weeks after injection

Trial details

NCT IDNCT05162326

SponsorBright Cell, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Jennifer Wang

949-333-3636 jenniferw@brightcellinc.com

View on ClinicalTrials.gov More Nasolabial Fold Wrinkles trials