New ointment shows promise for rare skin condition

NCT ID NCT05295732

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 study tested an ointment called TMB-001 in 153 people aged 6 and older with X-linked or ARCI ichthyosis, conditions that cause dry, scaly, and cracked skin. Participants applied the ointment or a placebo daily for 12 weeks, with some continuing for maintenance. The goal was to see if TMB-001 could improve skin scaling and fissuring better than placebo.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

TMB-001 0.05% ointment

What this could lead to

If successful, this could provide a new topical treatment option to reduce severe skin scaling and fissuring in people with inherited ichthyosis.

What could go wrong

This is a completed Phase 3 trial, but results are not yet published. The improvement may be modest, and some people may not respond. Side effects from the ointment are possible.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

autosomal recessive congenital ichthyosis ichthyosis inherited ichthyosis recessive X-linked ichthyosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • About Skin Dermatology

    Centennial, Colorado, 80111, United States

  • Ambulatorio di Malattie Rare Dermatologiche e Immunopatologia Cutanea

    Florence, 50125, Italy

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • Associated Skincare Specialists

    New Brighton, Minnesota, 55112, United States

  • Austin Institute for Clinical Research

    Houston, Texas, 77056, United States

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas, 78660, United States

  • CHU de Nantes Hotel Dieu

    Nantes, 44093, France

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Children's Hospital of Philadelphia (CHOP)

    Philadelphia, Pennsylvania, 19104, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Department of Dermatology and Cutaneous Surgery, University of Miami

    Miami, Florida, 33136, United States

  • Dr. Chih-ho Hong Medical Inc.

    Surrey, British Columbia, V3R 6A7, Canada

  • Fondazione IRCCS Ospedale Maggiore Policlinico Milano, Area Materno Infantile - SC pediatria Pneumoinfettivologia

    Milan, Italy

  • Hopital Larrey CHU Toulouse

    Toulouse, 31059, France

  • Hopital Necker APHP

    Paris, 75015, France

  • Hôpital Femme Mère Enfant

    Bron, 69677, France

  • Katholisches Kinderkrankenhaus Wilhelmstift GmbH

    Hamburg, 22149, Germany

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Münster University Hospital

    Münster, 48149, Germany

  • North Sound Dermatology

    Mill Creek, Washington, 98012, United States

  • Optima Research

    Boardman, Ohio, 44512, United States

  • SickKids Hospital

    Toronto, Ontario, M5G 1X8, Canada

  • Stanford University School of Medicine

    Palo Alto, California, 94304, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • The Indiana Clinical Trials Center

    Plainfield, Indiana, 46168, United States

  • U.O. di Dermatologia Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale

    Bologna, 40138, Italy

  • U.O. di Dermatologia e Venereologia Universitaria

    Bari, 70124, Italy

  • U.O.C. di Dermatologia Dipartimento Pediatrico Universitario Ospedaliero

    Roma, 00165, Italy

  • U.S. Dermatology Partners

    Phoenix, Arizona, 85006, United States

  • University of Mississippi Medical Center (UMMC)

    Jackson, Mississippi, 39216, United States

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Virginia Clinical Research-Pariser Dermatology Specialists

    Norfolk, Virginia, 23502, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27104, United States

  • Wiseman Dermatology Research Inc.

    Winnipeg, Manitoba, R3M 3Z4, Canada

  • Yale Center for Clinical Investigation

    New Haven, Connecticut, 06519, United States