Abstract

Introduction: Dark spots, also referred to as hyperpigmentation, are regions of the skin that appear darker than the surrounding areas due to an overproduction of melanin, the pigment responsible for skin color. This study aims to assess the safety and effectiveness of a novel depigmentation treatment. Galapep™ is a proprietary ingredient designed to target hyperpigmentation through a synergistic blend of active ingredients, including lactic acid, gallic acid, niacinamide, tranexamic acid, and retinaldehyde. The cream’s formulation targets key pigmentation pathways, providing a comprehensive approach to skin brightening and evening out skin tone in healthy participants. Methods: The open-label, single-arm, single-center, prospective, interventional clinical study to evaluate the safety, efficacy, and in-use tolerability of the test treatment for depigmentation. Ethical approval was obtained from the Independent Ethics Committee, and all participants provided written consent. The study assessed changes in severity of hyperpigmentation by dermatological assessment using IGA scale, changes in melanin (pigmentation) level, erythema index using instrument Mexameter® MX 18. Evaluations were conducted at baseline, T30 minutes, Day 21, and Day 45 post-usage. Statistical analyses performed by SPSS (Version: 29.0.1.0) and Microsoft® Excel 2019 software, with results reported using p-values and confidence intervals at a 5% significance level. Results: Based on the clinical, and statistical analysis, the results obtained from the study showed that: Notably, the application of the test treatment provides to a remarkable reduction in melanin pigment levels, with decrease of 16.32% observed immediately post T30 mins of application compared to baseline. This reduction continued to demonstrate efficacy over time, with subsequent reductions of 27.64% and 33.84% after 21 and 45 days of continuous usage respectively, each accompanied by a highly significant p-value of <0.0001. Similarly, reductions in erythema were observed, with a 5.04% decrease compared to baseline post T30 mins of application, and further reductions of 11.50% and 18.12% after 21 and 45 days of usage, also displaying highly significant p-values <0.0001. 100% subjects experienced test treatment effective in lightening the dark patches and 100% subjects experienced test treatment satisfactory after use. Conclusion: ThriveCo Dark Patches Corrector Cream is a clinically proven solution designed to target dark patches by exfoliating the skin, promoting cell turnover, and inhibiting melanin production. This study demonstrates that the test product, formulated with the advanced Galapep™ complex, is both safe and effective in managing hyperpigmentation. The synergistic action of its active ingredients—lactic acid, gallic acid, niacinamide, tranexamic acid, and retinaldehyde—significantly reduces melanin production, promoting even skin tone. Clinical results further show a marked reduction in erythema levels, with participants experiencing a significant improvement in the severity of dark patches. These findings highlight the potential of Galapep™-based formulations as a reliable solution for safely reducing hyperpigmentation and improving skin clarity.

Keywords

hyperpigmentation, dark spots, dark patches, IGA scoring, melanin, erythema