TMB-001 for the Treatment of Congenital Ichthyosis
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
PATIENT ENROLLMENT FOR PHASE 2B OF THE STUDY IS NOW CLOSED
PHASE 3 WILL OPEN IN 2022
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
