A Randomized, Parallel, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Two Concentrations of Topical TMB-001 for the Treatment of Congenital Ichthyosis

Timber Pharmaceutical’s CONTROL study

About the CONTROL Study

The purpose of this Phase 2b study is to investigate the efficacy and safety of two concentrations of TMB-001 (topical isotretinoin) for the treatment of congenital ichthyosis (CI).

Study highlights

Participation in this study will last approximately 12 weeks and includes six visits to the study center. Additional time, up to 90 days (screening phase) before the study starts may be needed to see if you qualify for the study.

If you qualify for the study, you may be eligible to receive reimbursement for travel to and from the study center, as well as being compensated for your time.

Eligibility criteria

Study participants must be 9 years of age or older and have either autosomal recessive congenital ichthyosis-lamellar ichthyosis (ARCI-LI) or recessive X-linked ichthyosis (RXLI) subtypes of CI. Participants must have a minimum of 10% of their total body surface area affected by CI at baseline and be in good general health. Women who are pregnant or planning to become pregnant may not participate in the study.

For additional information, please visit www.ichthyosistrial.com

 

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