Preparation and clinical assessment of spironolactone-containing cream on hair growth in hirsute women

Spironolactone is a diuretic antihypertensive drug which has been shown to produce antiandrogenic effects. The antiandrogenic effects of topical spironolactone have been proved in animals. In this study, we tried to prepare an effective formulation of topical spironolactone and also we evaluated its clinical effects in human. The study was performed in two phases: different formulations of topical spironolactone were examined in the first phase. Spironolactone creams containing 2% drug were prepared in aqueous cream, buffered, vanishing, oily, and cold cream bases and then physico-chemical tests including assessment of visual characteristics (appearance), uniformity, apparent viscosity and spreadability, drug release from the base, and assay of active ingredient were performed on each cream. In the second phase, the best formulation was applied twice daily for 3 months in 12 patients aged 17-50 years who suffered from mild to moderate hirsutism localized to the face. The patients used about 1 gram of the selected cream on one side of their face and did not remove or manipulate hair from that area throughout the study. The 2% spironolactone cream containing aqueous cream base was the best cream with the greatest stability and desirable physico-chemical properties. The clinical trial results from monthly assessments up to 3 months showed a lack of effectiveness of this formulation on hair growth compared with the other side of the face. Hirsutism and hair growth were not influenced by the application of the spironolactone-containing cream during 3 month of treatment. Other formulations or drug doses should be sought in the future studies.