Efficacy and Safety of a PTPD-12-Containing Cream on Improvement in Hyperpigmentation: A Randomized, Split-Face Clinical Trial

Abstract

Background: Skin hyperpigmentation is caused by excessive melanin and can result from various factors, including ultraviolet exposure. Pentasodium tetracarboxymethyl palmitoyl dipeptide-12 (PTPD-12), an autophagy-inducing peptide, has shown potential in regulating melanogenesis in melanocytes and keratinocytes. Objective: To evaluate the clinical efficacy and safety of a topical cream containing PTPD-12 in treating facial hyperpigmented disorders. Methods: A prospective, randomized, split-face, controlled clinical trial was conducted over 8 weeks in 21 participants with bilaterally symmetrical facial hyperpigmentation. Subjects applied a PTPD-12-containing cream to one side of the face and a control cream to the other, twice daily. Melanin index (MI), erythema index, The Investigator Global Assessment (IGA) and Patient Global Assessment (PGA), and histological analysis were performed. Results: Treatment with PTPD-12 cream resulted in a significant reduction in MI from 216.93 +/- 45.57 at baseline to 194.69 +/- 38.70 at week 8 (mean change, -22.23 +/- 15.16; p<0.0001). The IGA score on the treated side (1.78 +/- 0.76) was significantly better than that of the control side (1.28 +/- 0.63; p=0.0011). Also, the PGA score was significantly higher on the treated side (2.05 +/- 0.80) compared to the control side (1.25 +/- 0.62; p=0.0020). Fontana-Masson staining revealed a visible decrease in epidermal melanin in areas treated with the PTPD-12 cream. No significant adverse effects were observed throughout the study. supporting its potential as a novel, safe, and effective therapeutic option for pigmentary disorders.