New ointment shows promise for rare skin condition

NCT ID NCT05295732

Completed Disease control Sponsor: LEO Pharma Source: ClinicalTrials.gov ↗

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

ICHTHYOSIS

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

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