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.
RCT Entities:
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.
Authors: Jörg Täubel; Alessandro Mazzetti; Georg Ferber; William Burch; Sara Fernandes; Avani Patel; Christopher S Spencer; Anne Freier; Claus Graff; Jørgen K Kanters; John Camm Journal: Clin Pharmacol Drug Dev Date: 2021-05-03