TMB-301: The ASCEND Study: Evaluating TMB-001 in the treatment of RXLI or ARCI- Ichthyosis

About this Study

The purpose of this study is to find out if Topical TMB=001 ointment is safe and effective for the treatment of moderate to severe congenital ichthyosis (CI) in subjects 6 years of age and older

Sponsor Protocol ID:TMB01-301
IRB Number:2022-293
Actively Enrolling
Phase 3
November 15, 2022
Eligibility Criteria
6 years old
Both Male and Female

Inclusion Criteria
  • Must be male or female, 6 years of age and older at Visit 2 (Baseline)
  • Female must be postmenopausal, surgically sterile, or use 2 acceptable forms of birth control
  • Has clinical diagnosis of congenital ichthyosis (CI) and has a genetic confirmation of either ARCI or RXLI subtypes of CI
  • The amount of CI affected skin in the Treatment Area at Baseline will be between a minimum of 10% and maximum of 9% of the total body surface area
  • History of moderate to severe disease at Screening

Exclusion Criteria
  • Pregnant, lactating, or is planning to become pregnant during the study
  • Has inflammatory skin diseases that confound the interpretation of results unrelated to ichthyosis
  • Has genetic abnormality consistent with non-lamellar type or syndromic ichthyoses
  • Previously failed on topical/oral retinoid therapy for treatment of CI
  • Has used ultraviolet treatment within 4 week prior to Visit 2 (baseline)
  • Has undergone systemic therapies using Vitamin A supplements or St John's Work within 4 weeks prior to Visit 2 (baseline)
  • Immunosuppressed or receives systemic immunotherapy
  • Has untreated secondary infections
  • Currently enrolled in an investigational drug or device study or has used within 30 days prior to Visit 2 (Baseline)

Categories Click category to view its trials.
Dermatology/Skin Care
Participating Locations
University Hospital - UMMC
Contact Information
Contact Name: Thy Huynh
Phone Number: 601-815-8000
Principal Investigator:Huynh, Thy N, M.D.
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