Publications by authors named "Jessica Raiz"
Article Synopsis
- The Phase 2b CONTROL study analyzed the safety and effects of a new topical isotretinoin formulation, TMB-001, on laboratory values in patients with congenital ichthyosis, specifically focusing on X-linked and autosomal recessive types over 12 weeks.
- Participants aged 9 and older were randomly assigned to receive either TMB-001 or a vehicle, with laboratory tests conducted at the beginning and end of the study to monitor for adverse effects.
- Results indicated that while some minor laboratory abnormalities were noted, none were clinically significant, suggesting that TMB-001 may be a safer alternative to traditional oral retinoids for treating congenital ichthyosis.
Background: Emollients and keratolytics are frequently used to manage symptoms of congenital ichthyosis (CI). Systemic retinoid treatment is complicated by teratogenicity and dose-limiting adverse effects.
Objectives: This analysis from the randomized Phase IIb CONTROL study investigated the characteristics of participants who responded to treatment with TMB-001, a novel topical isotretinoin ointment formulation.
Background: In two severe congenital ichthyosis subtypes, autosomal recessive lamellar ichthyosis (ARCI-LI) and X-linked recessive ichthyosis (XLRI), cutaneous manifestations include widespread scaling. Approved topical treatment options are limited to emollients and keratolytics.
Aim: This analysis from the randomized phase IIb CONTROL study assessed whether the efficacy and safety of TMB-001, a novel topical isotretinoin ointment formulation, differed between ARCI-LI and XLRI subtypes.