Funding sources The work was entirely supported by a grant of Cosmo S.p.A., Lainate (MI), Italy.
Cortexolone 17α-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0·05% cream
Article first published online: 2 JUN 2011
© 2011 The Authors. BJD © 2011 British Association of Dermatologists 2011
British Journal of Dermatology
Volume 165, Issue 1, pages 177–183, July 2011
How to Cite
Trifu, V., Tiplica, G.-S., Naumescu, E., Zalupca, L., Moro, L. and Celasco, G. (2011), Cortexolone 17α-propionate 1% cream, a new potent antiandrogen for topical treatment of acne vulgaris. A pilot randomized, double-blind comparative study vs. placebo and tretinoin 0·05% cream. British Journal of Dermatology, 165: 177–183. doi: 10.1111/j.1365-2133.2011.10332.x
Conflicts of interest L.M. is an employee at Cosmo S.p.A., Lainate (MI), Italy. G.C. is a consultant at Cosmo Research & Development S.p.A., Lainate (MI), Italy.
- Issue published online: 24 JUN 2011
- Article first published online: 2 JUN 2011
- Accepted manuscript online: 24 MAR 2011 12:36AM EST
- Accepted for publication 12 March 2011
Background Acne vulgaris is a disorder of the pilosebaceous unit in which the androgens contribute to its onset and persistence. The use of antiandrogens is therefore potentially effective; however, antiandrogens for topical use are not available on the market. Cortexolone 17α-propionate (CB-03-01; Cosmo S.p.A, Lainate, Italy) is a new potent topical antiandrogen potentially useful in acne vulgaris.
Objectives To evaluate the safety and the topical efficacy of CB-03-01 1% cream in acne vulgaris as compared with placebo and with tretinoin 0·05% cream (Retin-A®; Janssen-Cilag).
Methods Seventy-seven men with facial acne scored 2–3 according to Investigator’s Global Assessment (IGA) were randomized to receive placebo cream (n = 15), or CB-03-01 1% cream (n = 30), or tretinoin 0·05% cream (n = 32) once a day at bedtime for 8 weeks. Clinical efficacy was evaluated every 2 weeks including total lesion count (TLC), inflammatory lesion count (ILC), acne severity index (ASI) and IGA. Safety assessment included local irritancy score, laboratory tests, physical examination, vital signs and recording of adverse events.
Results CB-03-01 1% cream was very well tolerated, and was significantly better than placebo regarding TLC (P = 0·0017), ILC (P = 0·0134) and ASI (P = 0·0090), and also clinically more effective than comparator. The product also induced a faster attainment of 50% improvement in all the above parameters.
Conclusions This pilot study supports the rationale for the use of topical antiandrogens in the treatment of acne vulgaris. CB-03-01 1% cream seems to fit with the profile of an ideal antiandrogen for topical use.