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NCT05639933 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors
A Phase 2 study of Acneiform Eruption Due to Chemical and Xerosis Cutis, sponsored by Hoth Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 152
- Enrollment target
- 8
- Study locations
NCT05639933: Recruiting Phase 2 study of Acneiform Eruption Due to Chemical and Xerosis Cutis, sponsored by Hoth Therapeutics.
NCT05639933 is a Phase 2 study of Acneiform Eruption Due to Chemical and Xerosis Cutis that is actively recruiting participants, run by Hoth Therapeutics. The registered enrollment target is 152 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05639933, a Phase 2 study of Acneiform Eruption Due to Chemical and Xerosis Cutis, is actively recruiting participants, sponsored by Hoth Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 152 participants
- Enrollment target
- 8
- Study locations
Study Summary
The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities. The main questions it aims to answer are: * Determine the therapeutic effect of HT-001 for treatment of patients who develop acneiform rash undergoing Epidermal Growth Factor inhibitor (EGFRI) therapy using the acneiform rash investigator's global assessment scale \[ARIGA\] * Evaluate the safety of HT-001 during treatment Participants will apply HT-001 Gel once per day for 6 weeks, during which the effect on treating acneiform rash or other skin disorders induced by EGFRI therapy will be evaluated using different assessment tools to measure severity of rash, pain, and itching (pruritus), as well as the change in quality of life. The study will be completed in 2 periods: the first period is open-label (unblinded) and all patients will receive HT-001 topical gel with the active ingredient; the second period is blinded and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Researchers will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.
Primary Outcome
Proportion of patients with a grade ≤ 1 based on the Acneiform Rash Investigator's Global Assessment \[ARIGA\] Scale; novel 5-point scale 0-4 with score of 0 is clear and grade 4 being most severe
Conditions Studied
Interventions
- DRUG HT-001 2% Topical Gel
- DRUG HT-001 1% Topical Gel
- DRUG HT-001 0.5% Topical Gel
- DRUG HT-001 Placebo
Study Locations (8)
New York
- NYU Langone Health - Mineola
- Northwell Physician Partners Dermatology - New Hyde Park
- Montefiore Medical Center - The Bronx
California
- UCI Health - CIACC - Irvine
- UC Irvine - Chao Family Cancer Center - Orange
District of Columbia
- The George Washington University Medical Faculty Associates - Washington D.C.
Massachusetts
- Dana Farber Cancer Institute - Boston
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2023-07-19 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What NCT05639933 shows while recruiting
NCT05639933 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (14% higher).
The record links to 3 conditions, with Acneiform Eruption Due to Chemical appearing as the primary indexed condition, and to 4 interventions - of which HT-001 2% Topical Gel is the first listed.
NCT05639933 lists 8 locations in 5 states (New York, California, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05639933 about?
NCT05639933 is a clinical study titled "Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated With Epidermal Growth Factor Receptor Inhibitors". The goal of this clinical trial is to learn about HT-001 Topical Gel for treatment of EGFR inhibitor-induced skin toxicities. The main questions it aims to answer are: * Determine the therapeutic effect of HT-001 for treatment of patients who develop acneiform rash undergoing Epidermal Growth Facto...
What is the current status of trial NCT05639933?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2023-07-19. Estimated completion is 2026-12-30.
What conditions does trial NCT05639933 study?
This clinical trial studies the following conditions: Acneiform Eruption Due to Chemical, Xerosis Cutis, Paronychia.
What interventions are being tested in trial NCT05639933?
The interventions under investigation include: HT-001 2% Topical Gel (DRUG), HT-001 1% Topical Gel (DRUG), HT-001 0.5% Topical Gel (DRUG), HT-001 Placebo (DRUG).
Who is sponsoring clinical trial NCT05639933?
This trial is sponsored by Hoth Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639933 being conducted?
This trial has 8 study locations across California, District of Columbia, Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05639933's enrollment target sits among peer trials
152 452nd of 2000 higher than 1,548 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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