Journal Article

Safety and efficacy of Bakutrol(tm) Face Cream In the treatment of facial acne

Mehta, Anirudh, NT, Madan Mohan, Godavarthy, Ashok

2025

Overview

Acne occurs when hair follicles are clogged with dead skin cells and oil from the skin that forms a bump on the skin, called comedones.1,2 Acne can occur at all ages; however, it is the most common skin disease in the age group of 12 to 24 years, affecting about 80% of teenagers and young adults.2 According to the Global Burden of Disease Study 2019, acne is the eighth most common skin disease, with an estimated global prevalence of 9.4% for all ages.3 Over the last decade and a half, the prevalence has increased by around 5%.4 Multiple etiological factors are involved in the development of acne. Four key pathological processes include i) androgen-induced increased sebum hyperproduction, ii) altered follicular keratinization that leads to comedones, iii) colonization and proliferation of duct by Propionibacterium acnes, and iv) complex inflammatory process involving both innate and acquired immunity.4, 5 Genetics, diet, environmental pollution, social environment, and lifestyle are the etiological factors that contribute to the pathogenesis of acne.4,5 Several studies have found that acne adversely affects the social life, self-esteem, appearance, and quality of life of individuals. [...]acne is often co-morbid with mental disorders, including depression and anxiety. The study was conducted as per the clinical research guidelines established by the Supplements and Cosmetics Act, 1940 of India, Supplements and Cosmetics Rules, 1945 of India, Ethical Guidelines for Biomedical Research on Human Participants, 2006 of Indian Council of Medical Research (ICMR) in India, the principles enunciated in the Declaration of Helsinki and the ICH-harmonized tripartite guideline regarding Good Clinical Practice (GCP). Other key exclusion criteria were the use of systemic corticosteroids, antibacterial, immunosuppressant drugs, or abradant facial procedures in the past 30 days, the presence of other concurrent facial skin diseases, and patients who are photosensitive or who are likely to engage in activities that involve excessive or prolonged exposure to sunlight, patients with drug-induced acne, with menopausal disorders, had a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients and use of oral retinoid within six months of baseline visit. 2.3 Interventional agent and treatment:

• Publisher: A&V Publications
• Subject: Acne / Age / Corticosteroids / Cosmetics / Demographics / Etiology / Guidelines / Health services / Medical research / Mental disorders / Pathogenesis / Photosensitivity / Skin diseases / Statistical analysis / Young adults