A randomized double-blind placebo-controlled clinical trial to evaluate the effect of an Annurca apple supplement formula in androgenic alopecia

Abstract

Androgenic alopecia is the most common form of hair loss, affecting men and women at different ages. The role of natural bioactive compounds has gained increasing recognition as a potential means to address hair loss. There is great interest in oligomeric procyanidins, particularly procyanidin B2, which have been shown to possess hair-growing activity. Annurca (Malus pumila Miller cv Annurca) apple fruits have one of the highest amounts of oligomeric procyanidins, specifically of procyanidin B2, compared to more common apple cultivars. In this study, randomized double-blind controlled parallel group trial was performed to compare the efficacy of the Annurca apple fruit extract as nutraceutical AT HAIR-FUL AA® food supplement with a placebo in hair growth. AT HAIR-FUL AA® procyanidin B2 whole fruit (peel and pulp) is characterized by a complex mixture of polyphenolic compounds, especially chlorogenic acid (400 - 600 μg/g) and procyanidin B2 (60-100 μg/g). The products were assigned to 80 enrolled subjects with alopecia, divided into 2 groups: 40 subjects took AT HAIR-FUL AA® food supplement and 40 subjects took the alternative treatment (PLACEBO). Each group of volunteers underwent 180 days of treatment, with the intake of 2 capsules per day. After that, volunteers took nothing for 30 consecutive days (follow up). The AT HAIR-FUL AA® food supplement significantly affected hair loss: hair density and weight significantly increased and hair loss significantly decreased over time (p<0.001). Moreover, we observed a fairly good pleasantness and a good skin and gastro-intestinal tolerability of the product, confirming its compliance of use: the product did not have a significant effect on gastrointestinal disorder and stomach ache onset (p=0.41 and p=0.25, respectively). AT HAIR-FUL AA® food supplement could be used as potential agent to induce hair growth.