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A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging 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

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Trial Profile

A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging 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

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2025

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At a glance

  • Drugs Aprepitant (Primary)
  • Indications Acneiform eruptions; Exanthema; Pruritus; Skin disorders
  • Focus First in man; Pharmacokinetics; Therapeutic Use
  • Acronyms CLEER; CLEER-001
  • Sponsors Hoth Therapeutics

Most Recent Events

  • 10 Sep 2025 According to a Hoth Therapeutics media release, pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple U.S. sites.
  • 10 Sep 2025 According to a Hoth Therapeutics media release, the company announced that it has submitted its Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a novel topical therapeutic for skin toxicities associated with Epidermal Growth Factor Receptor inhibitors (EGFRi).
  • 29 Jul 2025 According to a Hoth Therapeutics media release, the company announced its engagement with ICON Clinical Research Limited ("ICON") to expand it's Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).Additional regulatory approval for the Phase II clinical trial is expected from potentially three EU countries in the upcoming months.

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