Second pivotal trial of TWIN for the treatment of acne vulgaris in USA
Phase of Trial: Phase III
Latest Information Update: 04 Sep 2018
At a glance
- Drugs Benzoyl peroxide/tretinoin (Primary)
- Indications Acne vulgaris
- Focus Registrational; Therapeutic Use
- Sponsors Sol-Gel Technologies
- 04 Sep 2018 As per FDA's feedback, the paediatric clinical studies are not required to support the future marketing application and long-term safety study will not be required, as long as the company demonstrates that the systemic exposure of TWIN is comparable to the reference-listed drug (RLD), according to a Sol-Gel Technologies media release.
- 04 Sep 2018 According to a Sol-Gel Technologies media release, the company has completed an End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) and reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) for TWIN in the treatment of acne vulgaris.
- 08 Aug 2018 According to the Sol-Gel Technologies, this trial is anticipated to start in the the fourth quarter of 2018 and data anticipated in 2019.