From in-vitro to in-vivo: Corporate development and efficacy of a topical hair growth agent derived from natural extracts.

摘要

Androgenetic alopecia (male pattern baldness) affects up to 50% of the world's population, propelling the development for a possible treatment. The hair follicle is influenced by several genetic and physiologic factors, which, when gone awry, lead to androgenetic alopecia. Vascular endothelial and keratinocyte growth factors are believed to be promoters of hair growth, as is inhibition of the proteasome complex. The cytokine IL-1alpha is also known to regulate follicle dynamics. The research objective described herein was an attempt to develop a botanical blend, which could mediate the above biomarkers, be successfully incorporated into a safe topical product and be evaluated for in-vivo efficacy. By using an arbitrary scoring system to evaluate in-vitro performance, botanical extracts were screened in cell culture and enzyme assays. A Design of Experiments analysis, utilizing analyses of variance and multiple linear regressions, was performed to derive an optimized blend of Lichochalcone, Saw Palmetto, Shiso and Green Rooibos for incorporation into the prototype formulation. After passing human irritancy and sensitization testing, these extracts were coupled with liposomes to create a final prototype that was also screened for long-term stability. The end product was used in a clinical-type trial, assessing its effectiveness to increase scalp hair density, promote anagen follicle activity and increase the growth rate of the hair fiber. The product was benchmarked by RogaineRTM Extra Strength (5% minoxidil) and Rovisomes Biotin (commercially available). The twelve-week study involved sixty-nine males experiencing varying degrees of androgenetic alopecia who underwent ¼" length haircuts and a series of digital imaging focusing on a transition zone area of interest. The three test products significantly increased hair density and the number of anagen follicles compared to baseline values. Growth rate was up regulated for users of the prototype and RogaineRTM. Subjective self-assessment of the products revealed the prototype to be the least effective in improving hair quality characteristics, but with no significant difference to the other two products. These results indicate the herbal blend of Lichochalcone, Saw Palmetto, Shiso and Green Rooibos, in a liposomal base, has the potential to be an effective topical treatment for androgenetic alopecia.