Development of Dermal Cream for the Treatment of Vitiligo and Study Their Efficiency by in-Vitro Assay Methods

Abstract

This study aimed to develop and evaluate a Nigella sativa (NS) dermal cream for its anti-inflammatory potential and safety in topical applications. NS seeds were collected, ground, and subjected to hydrothermal extraction. The filtered extract was concentrated at 100 °C and used to formulate a sterile dermal cream, which was stored under refrigeration for further analysis. The anti-inflammatory activity was assessed using the albumin denaturation assay, showing a clear concentration-dependent effect, with the highest inhibition of 68% at 500 µg/ml and an IC50 value of 71.02 µg/ml. Protease inhibition assays further demonstrated moderate inhibitory activity (IC50 = 90.38 µg/ml), indicating potential to protect skin proteins and tissues from inflammatory damage. The cream exhibited a pH of 6, within the ideal range for dermal formulations, and no irritation or adverse effects were observed during skin testing. Solubility studies revealed partial solubility in ethanol and chloroform, providing insights for formulation optimization. Collectively, these findings suggest that NS dermal cream is a safe, effective, and biocompatible natural formulation with anti-inflammatory and protease-inhibitory properties. This cream holds promise as a complementary therapeutic approach for inflammatory skin conditions, including vitiligo, and warrants further clinical evaluation to explore its efficacy, dosing, and potential synergy with conventional treatments.