I am an ophthalmologist involved in a project which requires some knowledge of cosmetic ingredients containing progesterone compounds ... Sam Bierstock, M.D. ++++++++++++++++++++++++++++++++++++++== From: vevy@ping.ch In the EU Progestogens are banned for cosmetic use under the provisions of Annex II, no. 194 of the Council Directive 76/768/EEC and its amendments. They are not listed as Japanese cosmetic ingredients while in the USA their topical use is not restricted in cosmetics providing claims for a product meet the cosmetic definition. On October 2, 1989 a Tentative Final Monograph on Topically-Applied Hormone-Containing Drug Products for OTC Human Use was published in the Federal Register (54 Fed. Reg. 40618-22). In its Tentative Final Monograph FDA found that "topically applied hormone-containing drug products for OTC human use are not generally recognized as safe and effective and are misbranded". No active ingredient was classified in Category I (i.e. safe and effective) but estrogens and progesterone were listed in Category II "drug not being GRAS/E" (Generally Recognized As Safe/Effective) as to effectiveness. According to references dating back to '60s the use of progesterone (5 mg/oz.) in creams stimulates the normal secretion of sebum and enhances the appearance of the skin. In 1979 Simpson and coworkers investigated the effect of topically applied progesterone (ethanolic solution) on sebum excretion rate finding that progesterone temporarily decreases seborrhea in females but not in males. Conversely Tamm et al. in 1982 showed that 11-alfa-hydroxyprogesterone (1%) applied twice daily on the forehead of normal volunteers decreases sebum secretion in both sexes possibly through a competitive inhibition of testosterone vis-a-vis 5-alfa-reductase. Progestogens and estrogens have been claimed, even in the last decades, to reduce wrinkles and fine lines by plumping the skin to prevent hair loss and to smooth acne-affected skin, but no scientifically sound data, as confirmed by the FDA statement, seem to have been provided. Giorgio Rialdi MD,PhD - Managing Editor of RELATA TECHNICA - International Journal on Dermopharmacological Research, Dermopharmaceutical Technology and Related Cosmetic Subjects.