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.
Male or Female aged greater than 19 years
Acne scars graded ≥ 3 on the 5-point ASRS
Four or more atrophic scars in the joints, genitals, perineum, and face except for the lips, eyes and nose
Atrophic scar lesions approximately 2 cm in diameter located on the cheeks or temple on both sides of the face
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
Parallel
TRTP-101
Biological/VaccineIntradermal injection
Placebo
Biological/VaccineIntradermal injection
[Phase 1] Number of Subjects with Dose Limiting Toxicity
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
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.
[Phase 2] Proportion of subjects achieving ≥ 1-grade improvement on the GAIS
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
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.
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