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

Timber CONTROL: Participating Trial sites:

United States:

Associated Skin Care Specialists

Principle Investigator: Steven Kempers
Address: Fridley, MN
Contact: Allie Horita, ahorita@associatedskincare.com 763-571-4200


Austin Institute for Clinical Research

Principle Investigator: Jefferey Poole
Study Coordinator: Michelle Bursavich
Address: Metairie, LA
Contact: mbursavich@atxresearch.com, 504-264-6455

Children’s Hospital of Philadelphia

Principle Investigator: Leslie Castelo-Soccio
Study Coordinator: Jasmine Hanks
Address: Philadelphia, PA
Contact: hanksj@email.chop.edu ; 215-954-5081

Cincinnati Children’s Hospital

Principle Investigator: Kalyani Marathe
Study Coordinator: Nichole Kamos
Address: Cincinnati, OH
Contact:  Nichole.Kamos@cchmc.org 352-256-5936

The Indiana Clinical Trial Center

Principle Investigator: Dr. Scott Guenthner
Study Coordinator: Nikki Mosley
Address: Plainfield, IN
Contact: nmosley@indianatrials.com, 317-837-6082

Medical Dermatology Specialists

Principle Investigator: Lindsay Ackerman
Study Coordinator: Katherine Delfin
Address: Phoenix, AZ
Contact: kdelfin@usdermpartners.com, 602-354 -5770 Ext 38

Stanford University

Principle Investigator: Joyce Teng
Study Coordinator: Elidia Tafoya
Address: Palo Alto, CA
Contact: etafoya@stanford.edu; 650-721-1227

Yale University

Principle Investigator: Christopher Bunick
Study Coordinator: Study Coordinator: Kelly Borges
Address: New Haven, CT
Contact: kelly.borges@yale.edu 203-785-5505

Australia

Prof. Dedee Murrell
Premier Specialists
Sydney, NSW
Study Coordinator: Helen Dickenson-Panas, 0414164 838 , premierspecialiststrials@gmail.com

Prof John Su
Murdoch Children’s Research Institute
Melbourne, VIC
Study Coordinator: Nicole Davidson, Nicole.davidson@rch.org.au

Dr. Tania Zappala
Queensland Children’s Hospital
South Brisbane, QLD
Study Coordinator: Amanda James; amanda.james@tri.edu.au

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