Abstract
Objective: To test the efficacy of a new topical vehicle formulation containing cetirizine in emu oil in treating inflammatory skin conditions. Methods: A single blind half body comparative study of patients with psoriasis, atopic and stasis dermatitis were all treated with midpotency topical steroid (desoximethasone) in propylene glycol base, desoximethasone and cetirizine in propylene glycol base, desoximethasone in emu oil base and desoximethasone with cetirizine dissolved in emu oil. Results: Based on patients’ ranking of creams’ efficacy, and supported by photographic data and investigators’ clinical assessment, results clearly indicated that desoximethasone and cetirizine in emu base was statistically more efficacious than either desoximethasone alone or with cetirizine in neutral propylene glycol base or desoximethasone in emu oil base (without cetirizine). Conclusions: Cetirizine and emu oil, having inherent anti-inflammatory and other beneficial properties synergistically, and by different biochemical pathways, enhance and magnify each other’s pharmaceutical effects that are useful in treatment of skin inflammatory diseases.
Highlights
Extensive investment of time and capital is required to obtain FDA approval to sell and market a new drug; this is a reason that, in the past 5 years, only three topical dermatological drugs were approved by the FDA [1,2]
A single blind half body comparative study of patients with psoriasis, atopic and stasis dermatitis were all treated with midpotency topical steroid in propylene glycol base, desoximethasone and cetirizine in propylene glycol base, desoximethasone in emu oil base and desoximethasone with cetirizine dissolved in emu oil
Based on patients’ ranking of creams’ efficacy, and supported by photographic data and investigators’ clinical assessment, results clearly indicated that desoximethasone and cetirizine in emu base was statistically more efficacious than either desoximethasone alone or with cetirizine in neutral propylene glycol base or desoximethasone in emu oil base
Summary
Extensive investment of time and capital is required to obtain FDA approval to sell and market a new drug; this is a reason that, in the past 5 years, only three topical dermatological drugs were approved by the FDA [1,2]. Pharmaceutical companies are primarily directing their efforts to develop and patent new delivery systems and formulations to more efficiently carry active ingredients (drugs) through the stratum corneum skin barrier. These new formulations include solid lipid nanoparticles, liposomes and niosomes, transferosomes, ethosomes, cyclodextrins, and sol-gel microcapsules [1,2]. Cetirizine dissolved in emu oil can either be a vehicle to dissolve and to carry an active ingredient through skin barrier and synergistically to potentiate its therapeutic effects, or a pharmaceutical product by itself This formulation, developed for this study, contains 4 ingredients: emu oil > 85% by weight, cetirizine nonsedating antihistamine 2% by weight, methylparaben preservative 0.2%, and propylene glycol that potentiates emu oil solvent and emulsifying properties As is further addressed in the discussion section, cetirizine dissolved in emu oil can either be a vehicle to dissolve and to carry an active ingredient through skin barrier and synergistically to potentiate its therapeutic effects, or a pharmaceutical product by itself.
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