Evaluation of the clinical efficacy and safety of “Anti-Dandruff Shampoo” in the treatment of dandruff

Dandruff (Pityriasis simplex) is a common embarrassing scalp disorder, affecting a large chunk of population. The yeast, Pityrosporum ovale is the causative microorganism of dandruff and due to its lipase activity it releases proinflammatory free fatty acids, causing dermal inflammation and tissue damage. Currently available treatment options have various limitations, either due to poor clinical efficacy or due to the compliance issues. Also, these drugs are unable to prevent recurrence, which is the commonest problem. This study was planned to evaluate the clinical efficacy and safety of “Anti-Dandruff Shampoo” in the management of dandruff. This study was a prospective, open, non-comparative, phase III clinical trial and was approved by the Institutional Ethics Committee. A total of 35 patients, who were diagnosed as suffering from dandruff, and who were willing to give informed written consent were included in the study. A baseline history was obtained and the baseline assessment included personal data, a description of symptoms and details of past medical history. All the patients were advised to apply the “Anti-Dandruff Shampoo”, twice a week for a period of 6 weeks. The predefined primary efficacy endpoints were reduction in dandruff lesions, reduction in overall scalp inflammation and healing of existing lesions. The predefined secondary safety endpoints measures were incidence of adverse events and overall patient compliance to the drug treatment. All the adverse events either reported or observed by the patients were recorded with information about severity, date of onset, duration and action taken regarding the study drug. Patients were allowed to voluntarily withdraw from the study if they experienced serious discomfort during the study or sustained serious clinical events requiring specific treatment. This study observed a significant reduction in the mean scores of itching and white scales of dandruff. The subjective evaluation revealed remarkable symptomatic and clinical improvement in 2 weeks period. The excellent antidandruff action of “Anti-Dandruff Shampoo” might have been due to the synergistic antifungal, anti-inflammatory and local immunostimulatory actions of its ingredients. Therefore, it may be concluded that, “AntiDandruff Shampoo” is effective and safe in the management of dandruff.