A Twelve Week Study Evaluating the Efficacy of a Novel Standardized Nutraceutical to Improve Acne and Skin Health

Abstract

INTRODUCTION

Although acne is generally viewed as the result of a localized immune response at the pilosebaceous unit, it is a condition with multifactorial etiology.  While conventional treatments have focused primarily on the four major pathogenic factors, nutraceuticals offer an alternative or complementary approach to address more systemic, intertwined mechanisms involved in acne pathogenesis. These include stress, diet and metabolism, skin and gut microbiome, hormonal fluctuations, oxidative stress, and immune function. Therapies which target these underlying mechanisms have gone largely unexplored as ways to address acne. Here, we present the results of a novel nutraceutical addressing these root causes in patients with non-cystic acne. 

DESIGN

This was a 12-week single-arm prospective study for adults aged 18-50 with facial non-cystic acne ranging from mild to severe. Subjects discontinued all acne medications and topicals prior to the start of the study.  Clinical assessments at baseline, week 4, 8 and 12 included IGA, inflammatory and non-inflammatory lesion counts, clinical grading of PIH/PIE, and texture.  Bioinstrumentation included corneometer, tewameter and sebumeter measurements. Questionnaires on perception of efficacy were also completed.

RESULTS

Fifty-one subjects were recruited with 39 subjects completing the study.  The majority were female (67%); racial/ethnic background was comprised of white/caucasian (41%), black (41%) and Asian (13%). Reasons for discontinuation were: lost to follow up/withdrawal (n=7), non-compliance (n=1) and adverse events (n=4). Significant and progressive improvements were seen starting at week 4 in IGA with 85% of subjects showing significant improvements for acne severity at week 12.  All lesion counts decreased over the duration of the study with a significant proportion of subjects seeing improvements in inflammatory lesion counts (69%) and non-inflammatory lesion counts (87%). Overall, clinical grading of skin quality parameters progressively improved throughout the duration of the study. Notably PIH/PIE parameters significantly improved in nearly 80% of subjects by week 12. Sebumeter measurements improved significantly with a decrease of 25% as early as week 4 and remained lower than baseline throughout the duration of the study. Skin hydration as measured by the corneometer improved as well.  Subjective impressions of improvement as measured by the questionnaire at 12 weeks showed subjects had ‘less breakouts’ (77%), ‘less oily skin’ (74%) and that their ‘acne had improved’ (87%).

CONCLUSION

The paucity of scientific evidence and lack of clinical data on the efficacy of CAM, including nutraceuticals, have limited their recommendation for use in acne.  This proof-of-concept study showed improvements in acne and skin parameters. Although more studies are needed, these results offer insight into the potential benefits of nutraceuticals addressing underlying mechanisms that up to now, have gone largely unexplored. Addressing root causes that contribute to a generalized inflammatory response leading to the development of acne may prove to be an important step in expanding our toolbox in providing more options for patients and improving skin health.