New ointment shows promise for rare skin scaling disease
NCT ID NCT04154293
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two strengths of a topical isotretinoin ointment (TMB-001) in 34 people aged 9 and older with congenital ichthyosis, a rare genetic skin condition causing severe scaling. The main goal was to see if the ointment could reduce scaling by at least 50% compared to a placebo ointment. The trial is now complete, and results will show whether this treatment is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Topical isotretinoin (TMB-001) ointment
- What this could lead to
- If successful, this could provide a new topical treatment to reduce severe scaling and improve skin appearance in people with congenital ichthyosis.
- What could go wrong
- This is a small Phase 2 trial with only 34 participants, so results may not apply to everyone. Topical isotretinoin can cause skin irritation, and the treatment may not work for all subtypes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
34 people
The number who actually took part.
- Started
-
Dec 2019
- Finished
-
Aug 2021
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
9 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autosomal recessive congenital ichthyosis-lamellar ichthyosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Austin Institute for Clinical Research, Inc
Metairie, Louisiana, 70005, United States
-
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
-
Medical Dermatology Specialists
Phoenix, Arizona, 85006, United States
-
Minnesota Clinical Study Center
New Brighton, Minnesota, 55112, United States
-
Murdoch Children's Research Institute, RCH
Melbourne, Victoria, 3052, Australia
-
Premier Specialists, The church
Kogarah, Sydney, NSW 2217, Australia
-
Queensland Children's Hospital
Brisbane, Queensland, 4101, Australia
-
Stanford University School of Medicine
Palo Alto, California, 94304, United States
-
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19140, United States
-
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
-
Yale Center for Clinical Investigation
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.