- Reaction score
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Cassiopea just released some info about the status of Breezula (CB-03-01) dose ranging trial. Here are the highlights (copied from their presentation):
Single 12-month study with interim analysis at 6 months
• Male subjects 18-55 years of age with mild to moderate Androgenetic Alopecia
• Co-Primary Endpoints:
o Changes from Baseline in TAHC [in number of non-vellus hairs] at Month 12
o The subject’s evaluation of treatment benefit via the HGA question at Month 12
• 400 subjects, 80 per treatment arm
• 5 arms: 2.5%, 5.0%, 7.5%, vehicle BID and 7.5% QD
• CRO: bioskin; 6 German sites and 1 Back up site
• First Patient In June 2017
• 326 of 400 patients enrolled as of 3 Nov 17
• Enrollment should be complete by year end 2017
• Interim results due 2Q 2018 and Topline 12 month results due 4Q 2018
Also, here's a link to the ingoing clinical study details: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003733-23/DE
Single 12-month study with interim analysis at 6 months
• Male subjects 18-55 years of age with mild to moderate Androgenetic Alopecia
• Co-Primary Endpoints:
o Changes from Baseline in TAHC [in number of non-vellus hairs] at Month 12
o The subject’s evaluation of treatment benefit via the HGA question at Month 12
• 400 subjects, 80 per treatment arm
• 5 arms: 2.5%, 5.0%, 7.5%, vehicle BID and 7.5% QD
• CRO: bioskin; 6 German sites and 1 Back up site
• First Patient In June 2017
• 326 of 400 patients enrolled as of 3 Nov 17
• Enrollment should be complete by year end 2017
• Interim results due 2Q 2018 and Topline 12 month results due 4Q 2018
Also, here's a link to the ingoing clinical study details: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-003733-23/DE