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

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.

Figure 1

Schematic representation of the study design: (a) consort flow diagram and (b) sequence of events and time line of the study.

Figure 2

Quantitative analysis indicating percentage reduction in acne lesions. Lesion counts of total acne including the inflammatory and the noninflammatory types at week 0 (100%), 4, 12, and 24 are represented. ^∗Statistical significance of P < 0.05, based on Student's t-test. The table provides the corresponding values as average ± SEM.

Figure 3

Representative skin lesion images before (week 0) and after (week 24) treatment. The different labels on the picture represent different patient ids including the site number (S1 or S2), patient number (###), and visit (V1 or V5).

Figure 4

Global acne assessment using modified Cook's scale: The data represent the modified Cook's scale analysis made during each visit (at week 9, week 4, week 12, and week 24). The error bars are average ± SEM.

Figure 5

Modified Ferriman–Gallwey scale for scoring hirsutism (mFGHS). The data represent the mFGHS analysis made during each visit (baseline or week 0, week 4, week 12, and week 24). The error bars are average ± SEM.

Figure 6

Distribution of menstrual cycle variation among the subjects during the study period. The different bar patterns represent the menstrual cycle distribution in days among the patients having 25–30-day, 30–35-day 35–45-day, or >45-day cycle, respectively. The enrolled patients displayed normal hormonal levels.

Figure 7

Variation in hormone levels before and after treatment with Tracnil™. The different hormone levels at week 0 (black bar) and at week 24 (grey bar) are presented as average ± SEM. (a) analyzes LH and FSH levels. (b) compares testosterone total and free levels (i and ii) and androstenedione and dehydroepiandrosterone sulfate levels (iii and iv). Statistical analysis using Student's t-test (P > 0.05) was used to assess any significant changes in levels.

Figure 8

Likert scale analysis (scale of 0–5) for psychological assessment of patients with acne following treatment. The assessment parameters are listed on the left, and the bars correspond to the response at week 0 or at week 24.