Abstract
Cellulite is a prevalent cosmetic concern among postpubertal women, and the efficacy of conventional topical therapies remains limited. Green coffee bean extract (GCBE) exhibits antioxidant and lipolytic activities relevant to cellulite management; however, its topical performance is constrained by poor skin penetration and retention. This study clinically evaluated the efficacy of a GCBE-loaded solid lipid nanoparticle (SLN) cream for the topical treatment of cellulite. In a randomized, double-blind clinical trial, healthy female participants with thigh and gluteal cellulite applied either GCBE-SLN cream (0.5% w/w) or an equivalent free GCBE cream twice daily for three months. Clinical outcomes included visual cellulite grading, body weight, thigh and gluteal circumference, cellulite severity scoring, and ultrasound assessment of subcutaneous fat thickness. Compared to the free GCBE group, the SLN-based formulation produced significantly superior outcomes after three months of treatment, evidenced by greater reductions in thigh and gluteal circumference (p = 0.0239 and p = 0.0470, respectively) and a marked decrease in subcutaneous fat thickness (p < 0.0001), alongside marked improvements in visual grading (p = 0.041) and overall skin appearance. No treatment-related adverse effects were observed throughout the study. The results concluded that the GCBE-SLN cream represents a safe, non-invasive, and effective cosmeceutical strategy for cellulite management, supporting its further development as a clinically validated and commercially viable topical formulation.
Introduction
Cellulite, clinically referred to as gynoid lipodystrophy, is associated with lipodystrophy. This condition, whether of genetic or acquired origin, is characterized by the body’s impaired ability to generate and sustain healthy fat tissues [1]. Cellulite is a common, benign, painless, yet distressing dermatological condition characterized by a dimpled or puckered skin surface and affects the vast majority of post-pubertal women [2]. Estimates suggest that up to 98% of women of all races experience some degree of cellulite during their lifetime, particularly in high-fat storage areas, including the thighs, buttocks, and hips. It is characterized by a dimpled, “orange peel”-like appearance or mattress-like appearance of the skin, resulting from herniation of subcutaneous fat into the dermis, fibrotic changes in the connective tissue septae, and localized inflammation. Despite its association with adipose tissue, cellulite is not considered a clinical manifestation of obesity, and weight reduction methods will not work well for the condition. Moreover, cellulite can occur even in young women with a normal body mass index. Still, excess weight tends to worsen its appearance, especially when combined with other contributing factors such as genetic predisposition and hormonal imbalances, stress, unhealthy eating habits, prolonged periods of immobility, and a sedentary lifestyle. Despite being medically non-threatening, the psychological consequences of cellulite are enormous, with most of the affected patients claiming decreased self-esteem and poor body image [1], [3], [4], [5].
Cellulite pathophysiology is multifactorial. Some of the factors are sex hormones (particularly estrogen), connective tissue remodeling, adipocyte hypertrophy, vascular insufficiency, low-grade inflammation, and age-related skin thinning [6]. Such physiological and structural alterations result in irregularities of the skin and nodularity. Histologically, cellulite is linked with thickened fibrous septae, dilated blood vessels, and distorted collagen structure [7].
Successful treatments of cellulite are still out of reach. Several alternative treatments have been studied, such as subcision, energy (e.g., lasers, radiofrequency), injectables, massage, and topical agents. Topical treatments are better among the above therapies since it is a non-invasive modality [8]. Topical agents used to treat cellulite have several mechanisms of action, such as improving microcirculation, suppressing lipogenesis and simultaneously promoting lipolysis, restoring tissue structure of the dermis and subcutaneous tissues, and preventing or inhibiting the formation of free radicals [9]. Despite the existence of a vast array of cosmetic and medical procedures, there has been little clinical data to support their efficacy, and no treatment has so far been shown to permanently fix cellulite [10].
Green coffee bean extract (GCBE) is a polyphenol extract of unroasted Coffea arabica seeds that are rich in chlorogenic acid, caffeine, and other polyphenols. These substances have been found to possess lipolytic, antioxidant, anti-inflammatory, and vasodilatory activities, all of which are useful in the treatment of cellulite [11], [12], [13]. Chlorogenic acid (CGA) has been regarded as the key bioactive substance that led to the traditional application of green coffee bean extract in cellulite management via several pathways. CGA is capable of inhibiting the synthesis of fatty acids and oxidizing them, as well as suppressing the expression of acetyl-CoA carboxylase [14]. Moreover, Ilmiawati et al. (2020) proved that green coffee extract suppresses lipogenesis and stimulates lipolysis. One of the main causes of cellulite is excessive fat accumulation in adipose tissue; hence, stimulation of lipolysis represents an important therapeutic strategy for its management [15].
However, GCBE faces a challenge; being a hydrophilic drug, its topical absorption is limited because of its poor ability to partition into the lipid-rich stratum corneum. The fraction that does penetrate is quickly taken up into the circulation and rapidly cleared by cutaneous blood flow, resulting in minimal tissue retention. [16], [17].
This has led to increasing interest in advanced topical delivery systems, such as nanoparticles, to enhance therapeutic outcomes. Nanoparticles possess distinctive advantages over conventional emulsions, primarily due to their nanoscale size, which facilitates penetration across lipophilic barriers [18]. Among various nanocarriers, solid lipid nanoparticles (SLNs) offer multiple benefits, including low production cost, high physical stability, enhanced protection of encapsulated bioactives, and the ability to provide sustained drug release when compared with liposomes and niosomes. In addition, SLNs exhibit a more favorable safety profile than polymeric nanoparticles, supporting their suitability as delivery systems. Their composition from biocompatible and biodegradable physiological lipids, along with the solvent-free preparation methods commonly employed, further reinforces their recognition as safe and effective carriers for pharmaceutical and cosmeceutical applications [18], [19]. These properties make them especially suitable for delivering bioactives targeting adipose tissue and fibrotic structures involved in cellulite.
To avert the anticipated hampered permeation of hydrophilic GCBE through the skin, we previously formulated and optimized a GCBE-loaded SLN cream. This formulation demonstrated excellent physicochemical stability, spreadability, pH compatibility, and prolonged drug release, making it suitable for topical application. The formulation achieved high drug entrapment efficiency and uniform distribution, suggesting its potential for clinical use [20].
Building on these preclinical results, the present study evaluates, for the first time, the clinical efficacy and safety of a GCBE-loaded SLN cream in the management of cellulite by using a randomized, controlled design. As the marketed GCBE (0.5% w/w) cream was not officially available in Egypt at the time the clinical investigation was conducted, we incorporated GCBE in the prepared cream base at the same concentrations as the proposed GCBE-loaded SLN cream for the sake of comparison.
Primary outcomes included changes in cellulite grade, thigh and gluteal circumference, and subcutaneous fat thickness measured by ultrasonography, while secondary outcomes assessed patient-reported tolerability and satisfaction.
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Materials
Green coffee bean extract (GCBE) was purchased from Biofinest (USA). Tween 80, olive oil, glycerol, soft paraffin, and beeswax were purchased from AlNasr Pharmaceutical Chemicals Co. (Cairo, Egypt). Geleol was generously donated by Gattefossé (Saint-Priest Cedex, France). Propylene glycol was purchased from Alpha Chemika (Mumbai, India). Borax, methylparaben, and propylparaben were provided by Sigma-Aldrich (USA). All other used chemicals were of analytical grade.
Yomna A. Moussa, Mahmoud H. Teaima, Maha H. Ragaie, Nashwa M. Adel, Mohey M. Elmazar, Dalia A. Attia, Mohamed A. El-Nabarawi, Nano-boosted green coffee bean extract cream for enhanced anti-cellulite topical therapy: A randomized clinical trial, Next Nanotechnology, Volume 10, 2026, 100695, ISSN 2949-8295, https://doi.org/10.1016/j.nxnano.2026.100695.
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