An Open-Label Randomized Multicenter Study Assessing the Noninferiority of a Caffeine-Based Topical Liquid 0.2% versus Minoxidil 5% Solution in Male Androgenetic Alopecia.

BACKGROUND: Androgenetic alopecia is a condition with a high prevalence worldwide and affects both males and females. Currently, only 2 approved treatments exist: finasteride (males only) and minoxidil 2 or 5% solution (males and females). METHODS: We conducted a randomized, open-label, multicenter noninferiority study to determine whether a caffeine-based 0.2% topical liquid would be no less effective than minoxidil 5% solution in males (n = 210) with androgenetic alopecia. The primary end point was the percentage change in the proportion of anagen hairs from baseline to 6 months using a frontal and occipital trichogram. RESULTS: At 6 months, the group of the 5% minoxidil solution showed a mean improvement in anagen ratio of the trichogram of 11.68%, and the group of the 0.2% caffeine solution had an anagen improvement of 10.59%. The difference of mean values between both groups was 1.09%. The statistical analysis was performed and reported in accordance with the CONSORT Guidelines 2010 for reporting of noninferiority and equivalence randomized trials. CONCLUSION: A caffeine-based topical liquid should be considered as not inferior to minoxidil 5% solution in men with androgenetic alopecia.

Clinical evaluation of an Indian polyherbal topical formulation in the management of eczema.

OBJECTIVES: To evaluate the efficacy and safety of a topical application of Herbavate cream (Troikaa Pharmaceuticals Ltd, Ahmedabad, India), a polyherbal formulation in the management of outpatients with eczema. DESIGN: This was an open label design. SUBJECTS AND SETTING: One hundred and fifty (150) outpatients with a clinical diagnosis of eczema and meeting the eligibility criteria used topical Herbavate twice daily for 4 weeks. Change in symptom score for eczema (erythema, scaling, thickening, and itching) was assessed weekly using a 4-point score. The trial was carried out at Civil Hospital, Ahmedabad, Seth V.S. Hospital, Ahmedabad, and Stanley Medical College, Chennai. OUTCOME MEASURES: The primary outcome measure was a change in symptom score at 4 weeks as compared to baseline scores. The secondary outcome measure was a weekly change in symptom score as compared to the previous visit. Local tolerance was judged by development of side effects at site of application. RESULTS: Clinical improvement in symptom score at the end of study as compared to baseline was significant for all symptoms assessed (p < 0.001). Significant reduction in symptoms scores was observed from end of week 1. Local tolerance was good, with only 5 patients reporting side effects that improved with continued use. No patient withdrew due to side effects. CONCLUSIONS: Herbavate, a topical polyherbal formulation, appears to an attractive alternate option for the management of outpatients with eczema.