Atrophic Scar
Conditions
Brief summary
The purpose of this clinical trial was to evaluate the safety and efficacy of a single administration of TRTP-101 in adults with atrophic scars.
Detailed description
A phase 1 clinical trial designed to evaluate dose-limiting toxicity (DLT) following single-dose administration of TRTP-101 into four or more atrophic scar sites. Subsequently, a phase 2 clinical trial will be conducted using a placebo-controlled, split-face design to evaluate the safety and efficacy of TRTP-101. Eligible subjects will have atrophic scars approximately 2 cm in diameter located on both sides of the face (e.g., the cheek or temple areas), and TRTP-101 and placebo will be administered to the respective sides of the face.
Interventions
BIOLOGICALTRTP-101
Intradermal injection
BIOLOGICALPlacebo
Intradermal injection
Sponsors
CellinCells
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The Phase 1 study is conducted as an open-label trial, whereas the Phase 2 study is designed as a randomized, double-blind trial.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or Female aged greater than 19 years * Acne scars graded ≥ 3 on the 5-point ASRS \[Phase 1\] * Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose \[Phase 2\] * Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face * A response of "dissatisfied" or worse on the Subject Acne Scar Self-Assessment Scale
Exclusion criteria
* History of cell therapy * Treatment of Dermal resurfacing, Chemical/Mechanical Peel and Skin Photorejuvenation * Treatment of Hyaluronic acid/collagen skin filler, non-permanent soft tissue filler and fat grafting * Positive for virus infection * Use of Anticoagulant therapy or NSAIDs * Thrombocytopenia or other coagulation disorder * History of keloid scars * Infectious disease or other dermatitis in the area of the atrophic scar * Use of Immunosuppressant, immunomodulating drug, anticancer drug or radiation therapy * Use of systemic steroid medication * History of hypersensitivity or severe allergic reactions (e.g., anaphylaxis, Guillain-Barre syndrome, etc.) * Use of retinoid medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [Phase 1] Number of Subjects with Dose Limiting Toxicity | within 4 weeks | Dose Limiting Toxicity is defined as Grade ≥ 3 adverse drug reaction according to CTCAE criteria for 4 weeks after administration of TRTP-101 |
| [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement from baseline in ASRS | 12, 24 weeks after treatment | Proportion of subjects with ≥ 1-grade improvement from baseline in ASRS (Acne Scar Rating Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers using a standardized photoguide \*The Acne Scar Rating Scale (ASRS) is a 5-grade scale ranging from 0 to 4 (0 = Clear, 1 = Very mild, 2 = Mild, 3 = Moderate, and 4 = Severe). Higher grades indicate greater severity of atrophic scars and therefore a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS | 12, 24 weeks after treatment | Proportion of subjects with ≥ 1-point improvement from baseline on the GAIS (Global Aesthetic Improvement Scale) at 12, 24 weeks after treatment, as assessed by independent reviewers. \*The Global Aesthetic Improvement Scale (GAIS) is a 5-grade scale ranging from -1 to 3 (-1 = Worse, 0 = No change, 1 = Improved, 2 = Much improved, and 3 = Very much improved). Higher grades indicate greater aesthetic improvement and therefore a better outcome. |
| [Phase 2] Distribution of subjects by treatment satisfaction score | 12, 24 weeks after treatment | Distribution of subjects by treatment satisfaction score at 12, 24 weeks after treatment, assessed using the Subject Acne Scar Self-Assessment Scale. \*The Subject Acne Scar Self-Assessment Scale is a 5-grade scale ranging from -2 to +2 (-2 = Very dissatisfied, -1 = Dissatisfied, 0 = Somewhat satisfied, +1 = Satisfied, and +2 = Very satisfied). Higher grades indicate greater satisfaction with acne scars and therefore a better outcome. |
Countries
South Korea
Contacts
CONTACTHyeJung Park
PRINCIPAL_INVESTIGATORJonghee Lee, MD
Samsung Medical Center
Outcome results
None listed