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NCT05162326 | NOT YET RECRUITING | Nasolabial Fold Wrinkles

BC-101 in Treatment of Nasolabial Fold Wrinkles
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.

Condition or disease

Nasolabial Fold Wrinkles

Intervention/treatment

BC-101

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 9 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1/2 Study of the Safety and Efficacy of BC-101 in Treatment of Nasolabial Fold Wrinkles Via Subcutaneous/Intradermal Injection
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2026-02-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
BC-101 in Treatment of Nasolabial Fold Wrinkles

Location Details

NCT05162326

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Locations

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