Efficacy and Safety of Tracnil™ Administration in Patients with Dermatological Manifestations of PCOS: An Open-Label Single-Arm Study.

Ezhil Arasan Ramanan,K R Radha Anbu,Margaret Michael,Sailatha Ravi

doi:10.1155/2020/7019126

Ezhil Arasan Ramanan, K R Radha Anbu + Show 2 more

Open Access

https://doi.org/10.1155/2020/7019126

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Abstract

Myo-inositol's role in improving acne by reducing hyperandrogenism has been demonstrated in PCOS patients. Inositol and associated molecules display inhibitory properties against 5-α reductase, COX-2, and lipase enzymes in addition to their antimicrobial and anti-inflammatory properties. However, the role of myo-inositol is not well established in women patients with normal hormone levels but with clinical manifestations of PCOS. In this study, we evaluate the efficacy of Tracnil™, a combination of myo-inositol with folic acid and vitamin D3, in resolving acne in overweight women of menstruation age displaying normal hormone levels. It is a single-arm study conducted at 2 centers including 33 women with acne, hirsutism, and menstrual irregularities. Acne and hirsutism were assessed by manual lesion count, modified Cook's scale, and modified Ferriman–Gallwey hirsutism score (mFGHS). Hormone levels and safety parameters were assessed throughout the study. Our results show that Tracnil™ monotherapy could drastically reduce acne-related lesions of both inflammatory and noninflammatory types as quickly as 8 weeks. Additionally, it improves hirsutism and menstrual irregularities. Adverse reactions were negligible during the whole study period with no drastic side effects reflected by a modulatory effect on hormone levels. Despite the subjects having normal hormone levels, the acne treatment with myo-inositol and vitamin D3 shows improvement in hirsutism and regularization of menstrual cycle. Therefore, we attribute the mechanism of action of Tracnil™ to modulation of receptor sensitivity to sex hormones or other downstream processing events. Tracnil™ may be considered as a first-line treatment for dermatological manifestations of PCOS even in the absence of significant hormonal abnormalities. This treatment is practically implementable in a dermatologists's office practise.

Highlights

Acne vulgaris is a disease of the pilosebaceous unit, characterized by release of inflammatory mediators, hyperkeratinization, increased sebum production, and Cutibacterium acnes colonization [1]
Hirsutism, alopecia, and acanthosis nigricans are some of the common dermatological manifestations in women with polycystic ovarian syndrome (PCOS) [5, 6]
TM In this single-arm study, efficacy and safety of oral Tracnil were assessed in thirty-three female patients with associated symptoms of mild-to-moderate acne and hirsutism

Summary

Introduction

Acne vulgaris is a disease of the pilosebaceous unit, characterized by release of inflammatory mediators, hyperkeratinization, increased sebum production, and Cutibacterium acnes colonization [1]. Persistence of acne in about 12% of women beyond teenage may reflect underlying systemic diseases or syndromes [3, 4]. Hirsutism, alopecia, and acanthosis nigricans are some of the common dermatological manifestations in women with polycystic ovarian syndrome (PCOS) [5, 6]. Myo-inositol administration has been widely shown to modulate hormonal fluctuations and improve fertility in patients with PCOS, by correcting insulin resistance [9,10,11]. TM folic acid and vitamin D3 (as Tracnil ) is highly effective in resolving acne in overweight women of menstruation age displaying normal hormone levels. Our study addressed the menstrual irregularities and other dermatological manifestations that possibly suggest an underlying PCOS

Subjects and Methods

Results

Baseline

Conflicts of Interest