BC-101 in Treatment of Nasolabial Fold Wrinkles
ConditionNasolabial Fold Wrinkles
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorBright Cell, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BC-101
Treatment groups
9 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov