Oral and externally used dermatological preparation for acne vulgaris employing herbal extracts have been developed and standardized, the herbal extracts used here were of the plants described in ayurvedic treatise like Bhavprakasha Nighantu and Charak Samhita. The efficacy of the treatment using the oral formulation with or without external preparation has been assessed through conduct of Phase II clinical trials in 53 patients for 4 weeks in a randomized, double-blind, placebo-controlled fashion and following Good Clinical Practices guidelines. The results were statistically analyzed and indicated that combination of use of internal and external preparation showed better efficacy as compared to the use of oral formulation alone.