Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Timber Pharmceuticals LLC

Stanford Investigator(s):

Intervention(s):

  • Drug: Isotretinoin
  • Other: Vehicle

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

9 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elidia Tafoya
650-724-1982
Recruiting