The ASCEND Study: Evaluating TMB-001 in the Treatment of RXLI or ARCI Ichthyosis
Public ClinicalTrials.gov record NCT05295732. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The ASCEND Study: A Phase III, Multicenter, Double Blinded Vehicle Controlled Study of TMB-001 - With a Parallel Optional Maximal Use Arm - in the Treatment of RXLI (X-linked) or ARCI Ichthyosis in Subjects Aged ≥6 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a randomized, double-blind and vehicle-controlled Phase III study to evaluate the safety and efficacy of topical TMB-001 0.05% ointment for the treatment of congenital ichthyosis (CI) in subjects with either the RXLI or ARCI subtypes. In addition, a subset of preselected centers will recruit subjects in parallel with either the RXLI or ARCI subtypes for enrollment into an Optional Maximal Use arm for evaluation of the systemic exposure and safety of topical TMB-001 0.05% ointment for the treatment of CI. The Phase III Study is designed in three periods: \- Period 1 - Induction (3 weeks): At the beginning of the 3-week Induction Period, eligible subjects will be randomized (2:1 ratio) to either TMB-001 0.05% once-a-day (QD) or Vehicle QD treatment, with use of mandatory standardized bland emollient (Cetaphil™) provided by the Sponsor. \- Period 2 - Treatment (9 weeks): The dosing frequency in the 9-week treatment period will be increased in each treatment group to TMB-001 0.05% BID or Vehicle BID. Mandatory bland emollient will be discontinued. \- Period 3 - Maintenance (12 weeks): At Week 12, eligible subjects in the TMB-001 treatment group will be randomized (1:1 ratio) to an open-label treatment with TMB-001 0.05% BID or TMB-001 0.05% QD. To be eligible, subjects must have achieved a ≥1-point reduction in IGA score from Baseline. Subjects with less than a 1-point reduction in IGA score from Baseline will be discontinued from the study. Vehicle-treated subjects who achieved \<1-point reduction in IGA score from Baseline are eligible to cross over to the TMB-001 0.05% BID treatment group. Subjects with a ≥1-point reduction in IGA score from Baseline on vehicle will be discontinued from the study. Subjects at the end of the study or subjects discontinued from the study at any time will be followed-up for additional 2 weeks for AEs.
Study identification
- NCT ID
- NCT05295732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 20, 2022
- Primary completion
- Jun 16, 2024
- Completion
- Sep 22, 2024
- Last update posted
- May 21, 2026
2022 – 2024
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| U.S. Dermatology Partners | Phoenix | Arizona | 85006 | — |
| Stanford University School of Medicine | Palo Alto | California | 94304 | — |
| About Skin Dermatology | Centennial | Colorado | 80111 | — |
| Yale Center for Clinical Investigation | New Haven | Connecticut | 06519 | — |
| Department of Dermatology and Cutaneous Surgery, University of Miami | Miami | Florida | 33136 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46250 | — |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | — |
| Associated Skincare Specialists | New Brighton | Minnesota | 55112 | — |
| University of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | — |
| Optima Research | Boardman | Ohio | 44512 | — |
| Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Austin Institute for Clinical Research | Houston | Texas | 77056 | — |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | — |
| Virginia Clinical Research-Pariser Dermatology Specialists | Norfolk | Virginia | 23502 | — |
| North Sound Dermatology | Mill Creek | Washington | 98012 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05295732, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05295732 live on ClinicalTrials.gov.