Abstract

Acne is a common disease of the pilosebaceous units of the skin and topical therapy is recommended for the management of acne with comedolytic, anti-inflammatory agents, along with antimicrobials. However, topical application of these drugs leads to frequent adverse effects and also, there is an emergence of antibiotic resistance by Propionibacterium acnes. Furthermore, systemic antimicrobial usage has been causally associated with various adverse events. No simple recipe for the treatment can be provided. Treatment options vary with the stage and severity of the disease. So now a day's physicians prefer the herboformulations containing Melaleuca alternifoli, Azadirachta indica, Curcuma longa, Piper nigrum, Aloe vera, Citrus bergamia, Santalum album, Rosa centifolia, Carica papaya etc. than the allopathic drugs due to less or no side effects. Perfact gel is herbal formulation contains 5% of Melaleuca alternifoli (Tea tree oil) and Perfact tablet is polyherbal formulations and contains extracts of Azadirachta indica, Curcuma longa, and Piper nigrum, and the study was conducted to evaluate the efficacy and safety of perfect face, Perfect face tablets and both in the management of acne. In this contest, the present work is carried out which includes Uncontrolled randomized, open labelled, multicentric Phase III clinical trial using oral Ayurvedic multicomponent preparations with or without use of Ayurvedic dermatological formulation in three different hospitals from 15 July 2009 to 15 Oct 2009. One hundred fifty three patients (n=153) including 63 males and 90 females in the age group of 35-50 years were enrolled. Children below 18 years of age, patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders and those who refused to give informed consent were excluded from the study. Pregnant and lactating women were also excluded from the study. A baseline history was obtained in order to determine the patient's eligibility for enrolment in the trial. Thereafter all patients underwent a clinical examination and thorough skin examination was done the subjects are divided in to three groups. Group I received Perfect oral Tablet, Group II received dermatological gel (Perfact Face gel) and Group III received oral tablet and dermatological gel formula. Efficacy was assessed by the ability of perfact face gel and perfact face tablets to reduce the number of inflamed and non-inflamed lesions by using Leed's counting method and Cardiff index method. The group III shows more 12% as compared to group II. It was concluded that group III having more significant effect on the inflamed lesion as compared to group I and II treatment.

Highlights

  • Acne vulgaris, a chronic inflammatory disorder in adolescents consists of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules and often scars, on face, neck etc [1]

  • Demographic distribution of patient included in the study is shown in Table 1 and 2.In all 141 patients completed the study and there were twelve dropouts

  • A decrease in total number of white heads in the subjects was observed that was statistically significant at week 2 and week 4 when compared to the white heads at week 0. (Figure 1a), (Figure 2) Table 3 showing the change in total no .of lesions with treatment with perfact tablets

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Summary

Introduction

A chronic inflammatory disorder in adolescents consists of the pilosebaceous follicles, characterized by comedones, papules, pustules, cysts, nodules and often scars, on face, neck etc [1]. Sometimes it includes deeper skin lesions that are called Cysts (a closed sac beneath the skin or deeper that contain fluid or semisolid substances) [ 3] It is more common during teenage years but is known to happen across all age. Adult acne is becoming increasingly popular [4]. It is a disease of the skin which can be painful for those suffering from moderate to severe acne [5]. Acne vulgaris mostly affects the areas of skin with the densest population of sebaceous follicles [6] these areas include the face, the upper part of the chest, and the back. The earliest abnormalities in acne are: Increased sebum production due to which the skin looks greasy (seborrhea)

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