Individualized homeopathic medicines in treatment of acne vulgaris: Double-blind,randomized, placebo-controlled, pilot trial

Acne vulgaris is a follicular disorder affecting susceptible pilo-sebaceous follicles, primarily of the face, neck, and upper trunk and characterized by both non-inflammatory and inflammatory lesions. It is estimated to affect 9.4% of the global population with 10-20% of some form of disorder, making it the 8th most prevalent disease worldwide and thus affect quality of life (QoL). Topical agents and synthetic retinoid isetretinoin often produce excellent results. But its use is highly regulated due to its potential for severe adverse events, primarily tetragenocity, depression, xerosis, cheilitis and occasional hypertriglyceridemia. Various complementary and alternative medicine (CAM) modalities have been introduced and found to have an important role in management of acne; however, their recommendation for treatment is limited by lack of large-scale studies and evidence about their efficacy and safety profile. In this double-blind, randomized, placebo-controlled trial at D. N. De Homoeopathic Medical College and Hospital, 40 patients suffering from acne vulgaris will be randomized to receive either individualized homeopathic medicines (verum; n=20) or identical-looking placebo (control; n=20). We aim to address the feasibility issues of conducting a definitive efficacy trial of individualized homoeopathy in treatment of acne vulgaris and to investigate whether there are any differences in outcomes between these two groups over 2 months of intervention. Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI) will be used as the primary and secondary outcome measures respectively. Feasibility issues will be checked and comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.