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

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.

CONCLUSION

PTPD-12 cream significantly reduced melanin levels in facial hyperpigmentation, supporting its potential as a novel, safe, and effective therapeutic option for pigmentary disorders.