A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital Ichthyosis

• Status: Completed
• Trial end date: 2021-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy and safety of two concentrations of topically applied ointment formulation of isotretinoin called TMB-001 (0.05% and 0.1% isotretinoin) in subjects 9 years of age and older for the treatment of congenital ichthyosis (CI), including recessive X-linked ichthyosis (RXLI) and autosomal recessive congenital ichthyosis-lamellar ichthyosis (ARCI-LI) subtypes.

Funding Source FDA-OOPD

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Timber Pharmceuticals LLC
• Treatments: Isotretinoin

Criteria

Inclusion Criteria:

• Subject is male or female, 9 years of age or older at Visit 2 (Baseline)

• Subject has provided written informed consent

• Females of child bearing potential must be surgically sterile or agree to 2 forms of birth control

• Subject has clinical diagnosis of Congenital Ichthyosis with genetic confirmation of subtype

• Subject has between 10% and 90% total BSA affected by Congenital Ichthyosis

• Subject has at least 2 VIIS assessment areas with a scaling score of 3 or greater

Exclusion Criteria:

• Subject has inflammatory skin diseases unrelated to ichthyosis

• Subject has used other prohibited topical treatments in the assessment areas within certain days from baseline

• Subject has used systemic retinoids within12 weeks of baseline

• Subject has untreated secondary infections

• Subject has lesions suspicious for skin cancer or untreated skin cancers