Sol-Gel Reports Results of Twyneo in Two P-III Trials for Acne Vulgaris
Shots:
- The two P-III trials SGT-65-04 and SGT-65-05 involves assessing of Twyneo (qd) or vehicle cream in 858 patients in ratio (2:1) at 63 sites for 12 wks.
- The P-III study results SGT-65-04 & SGT-65-05 trial success in IGA (38.5%- 25.4% vs 11.5%- 14.7%)- absolute change from baseline of inflammatory lesion count (-21.6- -16.2 vs -14.8- -14.1)- absolute change from baseline of non- inflammatory lesion count (-29.7- -24.2 vs -19.8- -17.4)- well-tolerated
- Twyneo (FD) is an antibiotic-free compromising combination of tretinoin 0.1% and microencapsulated benzoyl peroxide 3% cream based on microencapsulation technology platform with expected NDA submission in H2’20
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